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    Summary
    EudraCT Number:2013-005345-36
    Sponsor's Protocol Code Number:D5610C00001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-05-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2013-005345-36
    A.3Full title of the trial
    An exploratory Phase 2, randomized, double-blind, placebo-controlled, parallel design study to evaluate the safety, tolerability, and pharmacodynamics of AZD1722 in CKD patients with type 2 diabetes mellitus and albuminuria
    A.4.1Sponsor's protocol code numberD5610C00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01847092
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorArdelyx, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportArdelyx, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace GmbH
    B.5.2Functional name of contact pointMedpace Regulatory Submissions
    B.5.3 Address:
    B.5.3.1Street AddressTheresienhöhe 30
    B.5.3.2Town/ cityMünchen
    B.5.3.3Post code80339
    B.5.3.4CountryGermany
    B.5.4Telephone number004989895571860
    B.5.5Fax number0049898955718160
    B.5.6E-mailreg.submissions@medpace.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAZD1722
    D.3.2Product code AZD1722
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtenapanor
    D.3.9.1CAS number 1234365-97-9
    D.3.9.2Current sponsor codeAZD1722 dihydrochloride
    D.3.9.3Other descriptive namedihydrochloride salt of AZD1722
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAZD1722
    D.3.2Product code AZD1722
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtenapanor
    D.3.9.1CAS number 1234365-97-9
    D.3.9.2Current sponsor codeAZD1722 dihydrochloride
    D.3.9.3Other descriptive namedihydrochloride salt of AZD1722
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAZD1722
    D.3.2Product code AZD1722
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtenapanor
    D.3.9.1CAS number 1234365-97-9
    D.3.9.2Current sponsor codeAZD1722 dihydrochloride
    D.3.9.3Other descriptive namedihydrochloride salt of AZD1722
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAZD1722
    D.3.2Product code AZD1722
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtenapanor
    D.3.9.1CAS number 1234365-97-9
    D.3.9.2Current sponsor codeAZD1722 dihydrochloride
    D.3.9.3Other descriptive namedihydrochloride salt of AZD1722
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic kidney disease (CKD) with type 2 diabetes mellitus and albuminuria
    E.1.1.1Medical condition in easily understood language
    Chronic kidney disease with diabetes and albuminuria
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare the effect of AZD1722 versus placebo on the changes in urine albumin-to-creatinine ratio (UACR) from Baseline to Week 12.
    E.2.2Secondary objectives of the trial
    • To investigate safety and tolerability of AZD1722
    • To investigate the pharmacodynamic effects of AZD1722 on urine albumin-to-creatinine ratio (UACR), eGFR (s-creatinine, and s-cystatin-c), blood pressure, p-NT-proBNP, s-cardiac troponin, u-aldosterone, p-renin activity, and bioimpedance.
    • To investigate the pharmacodynamic effects of AZD1722 on u-Na excretion, mean weekly stool consistency (BSFS) and stool frequency
    • To investigate the plasma exposure of AZD1722
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    An optional genetic substudy with a separate informed consent will include collection of a DNA sample for potential future research of genes related to the cardio-renal disease area or associated with drug response or drug metabolism.
    E.3Principal inclusion criteria
    1. Males or females aged 18 to 80 years, inclusive.
    2. Females must be non-pregnant, non-lactating and fulfilling one of the following:
    a. Post –menopausal defined as amenorrhoea for at least 12 months following cessation of all exogenous hormonal treatments and with follicle stimulating hormone (FSH) levels in the laboratory defined post-menopausal range.
    b. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral
    salpingectomy but not tubal ligation.
    c. Use of acceptable contraceptive method: IUD with spermicide, a female condom with spermicide, contraceptive
    sponge with spermicide, an intravaginal system (e.g., NuvaRing®), a diaphragm with spermicide, a cervical cap with spermicide, or oral, implantable, transdermal, or injectable contraceptives; or sexual abstinence.
    3. Males must agree to avoid fathering a child (or donating sperm), and therefore be either sterile or agree to use, from the time of randomization until 45 days after end of study, one of the following approved methods of contraception: a male condom with spermicide; a sterile sexual partner; use by female sexual partner of an IUD with spermicide, a female condom with spermicide, contraceptive sponge with spermicide, an intravaginal system (e.g., NuvaRing®), a diaphragm with spermicide, a cervical cap with spermicide, or oral, implantable, transdermal, or injectable contraceptives.
    4. Body mass index between 18 and 45 kg/m2, inclusive.
    5. Patients must have a history of type 2 diabetes mellitus and must be receiving 1 glucose lowering medication for at least 3 months prior to randomization
    6. Stage 3 CKD where the eGFR value collected at week -1 must be between 30-60 mL/minute/1.73m2 inclusive using the CKDEPI equation (Section 7.4.2)
    7. Urinary albumin: mean UACR 200 mg/g (spot urine) collected at Screening and Visit 2 (Week -1)
    8. Patient must be receiving an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) for at least 3 months prior to Screening, where the dose of the ACE inhibitor and/or the ARB is considered appropriate for that patient, and has been stable and maintained on that dose for at least 4 weeks prior to study randomization
    9. If treated with diuretics, the prescription should be stable for at least 4 weeks prior to study randomization
    10. Systolic blood pressure 130 mmHg
    11. Willing and able to sign informed consent.
    12. For inclusion in the optional genetic substudy, patients must fulfill all of the inclusion criteria described above and provide informed consent for the genetic sampling and analyses.
    E.4Principal exclusion criteria
    1. Urinary albumin: UACR > 3500 mg/g
    2. History of a renal transplant
    3. Blood pressure (BP) of MSSBP >180 mmHg or a MSDBP of >120 mmHg on two occasions during screening or run-in
    periods
    4. History of inflammatory bowel disease (IBD) or diarrhea predominant irritable bowel syndrome (IBS-D)
    5. Clinical sign of dehydration during screening or run-in periods
    6. Poorly controlled diabetes (fasting s-glucose >270 mg/dL) based on results collected at Visit 2 (Day -7)
    7. Acidosis (s-bicarbonate < 18 mmol/L) based on results collected at Visit 2 (Day -7) and obtained from the central lab for the study
    8. Hepatic dysfunction (alanine aminotransaminase [ALT] or aspartate aminotransaminase [AST]) >3 times the upper limit of normal based on central laboratory reference ranges) based on results collected at Visit 2 (Day -7) and obtained from the central lab for the study
    9. Any biopsy or imaging verifying intercurrent kidney disease other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis
    10. Any patient with cardiovascular disease as follows:
    a. Unstable angina pectoris within 3 months before study randomization;
    b. Myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 3 months before study randomization;
    c. Transient ischemic attack within 3 months before study randomization;
    d. Cerebrovascular accident within 3 months before study randomization;
    e. Obstructive valvular heart disease or hypertrophic cardiomyopathy;
    f. 2nd degree or 3rd degree atrioventricular block not successfully treated with a pacemaker;
    11. Serum sodium value <132mEq/L or >145mEq/L or serum potassium value <3.5mEq/L or >5.5 mEq/L on more than one occasion prior to randomization.
    12. Diarrhea or loose stools during the week before randomization defined as BSFS 6 and frequency 3 for 2 or more days.
    13. Pregnant or not willing to use appropriate contraception
    14. Any evidence of or treatment of malignancy within one year, excluding non melanomatous malignancies of the skin.
    15. Positive serology (hepatitis C or B infection, or human immunodeficiency virus) with evidence of significant hepatic
    impairment or WBC elevation according to the Investigator
    16. History of alcohol abuse, illicit drug use, significant mental illness, or any history of drug abuse or addiction within 12
    months of study enrollment.
    17. Scheduled for living donor kidney transplant, hemodialysis, peritoneal dialysis, or home HD during the 6 weeks following randomization.
    18. Patients taking Kayexalate® or a therapeutic equivalent sodium polystyrene sulfonate, or the phosphate binder Renvela®, (other phosphate binder are allowed), on a regular therapeutic regimen.
    19. Use of an investigational agent within 30 days prior to Screening
    20. Previous randomization into this study.
    21. Involvement in the planning and/or conduct of the study (applies to both Ardelyx staff and/or staff at the study site).
    22. Previous allogeneic bone marrow transplant (applicable only for genetic substudy and sampling).
    23. Non-leukocyte whole blood transfusion within 120 days of genetic sample collection (applicable only for genetic substudy and sampling).
    24. If, in the opinion of the Principal Investigator, the subject is unable or unwilling to fulfill the requirements of the protocol or has a condition which would render the results uninterpretable.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical endpoints:
    • UACR (Urine albumin-to-creatinine ratio)
    • eGFR (Serum Creatinine and Cystatin-C)
    • Blood pressure (MSSBP, MSDBP)
    • 24 hr Ambulatory blood pressure
    • 24 hr urinary Na
    • Mean weekly stool consistency (Bristol Stool Form Scale)
    • Mean weekly stool frequency
    • NT-proBNP and cardiac troponin (TnT)
    • Aldosterone and renin activity
    • Bioimpedance (Total body water, intra- and extracellular fluid volume)
    • 24 hr urinary Ca, P, pH, Cr, K
    • Exploratory biomarker analyses (potentially in future)
    • Pharmacogenetic sample analyses (potentially in future)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day -1 to Day 1 (prior to randomization), Weeks 3 and 12:
    • Sodium
    • Aldosterone

    Day 1 prior to randomization, Weeks 1, 3, 8, 12 and 14:
    • NT-pro-BNP (plasma), cardiac troponin (serum)
    • Renin activity (plasma)

    Baseline, 12 weeks:
    • Changes in UACR
    • Changes in related endpoints, such as eGFR , BP and U-Na
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Germany
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 112
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 140
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-23
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