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    Summary
    EudraCT Number:2007-005681-13
    Sponsor's Protocol Code Number:CLCI699A2206
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-01
    Trial results View 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 ConcernedFrance - ANSM
    A.2EudraCT number2007-005681-13
    A.3Full title of the trial
    A pilot, single-blind, forced-titration study to assess the hemodynamic and hormonal effects, safety and tolerability of the aldosterone synthase inhibitor LCI699 in patients with primary hyperaldosteronism
    A.4.1Sponsor's protocol code numberCLCI699A2206
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.3.2Product code LCI699
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeLCI699
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    hypertension artérielle par hyperaldostéronisme primaire
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039834
    E.1.2Term Secondary hypertension
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effects of LCI699 on mean 24-hour systolic blood pressure (SBP) as measured by ambulatory blood pressure monitoring (ABPM)
    E.2.2Secondary objectives of the trial
    • To examine the safety and tolerability of LCI699
    • To explore the effects of LCI699 on plasma and urine hormone levels and electrolytes
    • To determine the effects of LCI699 on mean 24-hour diastolic blood pressure (DBP)
    • To determine the effects of LCI699 on mean day time and night time SBP and DBP
    • To determine the pharmacokinetics of LCI699 following bid dosing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and/or female subjects 18 to 70 years of age (inclusive)
    • Female subjects must have been surgically sterilized (oophorectomy with or without hysterectomy) at least 6 months prior to screening. Surgical sterilization procedures must be supported with clinical documentation made available to sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF.
    OR:
    • Postmenopausal women must have no regular menstrual bleeding for at least 1 year prior to inclusion. Menopause will be confirmed by a plasma FSH level of ≥40 IU/L OR:
    • Male subjects must be using a double-barrier local contraception, i.e., spermicidal gel plus condom, for the entire duration of the study, up to Study Completion visit, and refrain from fathering a child or donating sperm in the three (3) months following last study drug administration.
    2. Body mass index of 18 to 34 kg/m2 at Screening. Subjects must weigh at least 50 kg to participate in the study.
    3. Diagnosis of primary hyperaldosteronism (PH) within the last 3 years, either with or without an aldosterone producing adenoma (APA). PH will be defined by aldosterone/renin ratio (ARR) ≥ 64 pmol/mU twice and an elevated aldosterone concentration (plasma ≥ 500 pmol/L or urinary ≥63 nmol/day) after 2-6 week washout of drugs interfering with the renin/ angiotensin / aldosterone system (RAAS).
    4. Diagnosis of hypertension at screening (systolic and/or diastolic OBP> 140/90 mmHg or on current antihypertensive treatment)
    5. Morning plasma cortisol (sampled between 08:00 and 09:00) > 200 nmol/l at screening and 60 min post-ACTH plasma cortisol should be > 500 nmol/l at baseline (Day -15).
    6. Able to provide written informed consent prior to study participation. Patient information and consent forms generated by the Investigator must be approved by the sponsor prior to submission to the Institutional Review Board (IRB). A copy of the patient information and consent forms approved by the IRB must be forwarded to the sponsor prior to study initiation.
    7. Able to communicate well with the investigator and comply with the requirements of the study.
    8. Registration to the French national welfare system
    E.4Principal exclusion criteria
    1. Patients with persistent hypokalemia (< 3.0 mmol/l despite oral administration of 6 g/day of KCl)
    2. Patients with renal impairment (estimated creatinine clearance < 60 ml/min by the MDRD formula).
    3. Use of any medication listed in paragraphe 6.6.5 within the four (4) weeks prior to dosing.
    4. Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
    5. Any blood donation or significant loss within 56 days of first dosing; donation of plasma within 7 days prior to first dosing.
    6. Anemia as defined by a hemoglobin level at screening or baseline (Day -15) ≤ 10 g/dl.
    7. Malignancy including leukemia and lymphoma (not including basal cell skin cancer) within the last 5 years
    8. Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any drug substance, but not limited to, any of the following: history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stappling, or gastric banding, currently active inflammatory bowel syndrome.
    9. Evidence of significant hepatic disease as determined by any one of the following: a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt, liver disease such as cirrhosis or chronic active hepatitis B and C, any alcohol related hepatic disease
    10. Current obstruction of the urinary tract or difficulty in voiding (due to mechanical or inflammatory conditions) that is likely to require intervention during the course of the study, or is regarded as clinically meaningful by the investigator.
    11. Any of the following significant laboratory abnormalities:
    • Clinically significant laboratory abnormalities, confirmed by repeat measurement, other than elevated serum creatinine, hyperglycemia, and glycosuria
    • Elevated fasting triglycerides > 500 mg/dl at Screening
    • ALT and AST > 2X upper limit of normal (ULN)
    • Total bilirubin > 2X ULN
    • Conjugated bilirubin > 1X ULN
    • A positive hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
    12. History of active substance abuse (including alcohol) within the past 2 years
    13. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
    14. Chronic use of NSAID or COX2 inhibitors or heparin. Aspirin up to 80 mg/day is allowed
    15. Chronic use of corticosteroids in any formulation (oral, topical, eye drops, inhaled)
    16. Known Keith-Wagener grade III or IV hypertensive retinopathy.
    17. History of hypertensive encephalopathy or cerebrovascular accident at any time prior to eligibility visit.
    18. Transient ischemic cerebral attack during the 3 months prior to eligibility visit.
    19. History of heart failure (NYHA Class I-IV).
    20. Unstable angina pectoris or myocardial infarction, or revascularization during the six months prior screening. Stable coronary heart disease patients treated with beta-blockers which cannot be interrupted.
    21. Second or third degree heart block without a pacemaker.
    22. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia. Patients with chronic atrial fibrillation (because of the difficulty to measure BP )
    23. Clinically significant valvular heart disease.
    24. Type 1 diabetes.
    25. Type 2 diabetes mellitus with poor glucose control as defined by HbA1c >8%
    26. Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
    27. History of unreliability or noncompliance to medical regimens or unwillingness to comply with the study protocol.
    28. Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety.
    29. Persons directly involved in the execution of this protocol.
    E.5 End points
    E.5.1Primary end point(s)
    to explore the pharmacodynamics (blood pressure, electrolyte and hormonal changes) and safety and tolerability of LCI699 following bid dosing.

    ABPM will be used to evaluate the primary endpoint of the study
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months15
    E.8.9.1In the Member State concerned days15
    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.1.3Elderly (>=65 years) Yes
    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 No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 12
    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 Decision2008-03-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-13
    P. End of Trial
    P.End of Trial StatusCompleted
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