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    Summary
    EudraCT Number:2007-001668-62
    Sponsor's Protocol Code Number:SLx-2101-07-08
    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:2007-08-15
    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 number2007-001668-62
    A.3Full title of the trial
    A pilot Phase IIa, randomised, double blind, placebocontrolled, crossover study to examine the safety, tolerability and pharmacodynamic effects on blood pressure of repeat oral doses of SLx-2101 5 mg or 10 mg once daily for up to 14 days in patients with hypertension.
    A.4.1Sponsor's protocol code numberSLx-2101-07-08
    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 SponsorSurface Logix, 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 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 SLx-2101
    D.3.4Pharmaceutical form Capsule, hard
    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 codeSLx-2101
    D.3.9.3Other descriptive namePhosphodiesterase (PDE-5) inhibitor
    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) 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, hard
    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
    MedDRA Classification
    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 effect of SLx-2101 5 mg or 10 mg dosed once daily for 14 days on supine and 2-minute standing peripheral systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate up to 24 h post-dose in patients with hypertension.
    E.2.2Secondary objectives of the trial
    • To determine the effect of single doses of SLx-2101 5 mg or 10 mg on supine and 2-minute standing peripheral SBP and DBP and heart rate in patients with hypertension.
    • To explore the effect of SLx-2101 5 mg and 10 mg dosed once daily for 14 days on 24 h ambulatory blood pressure and heart rate in patients with hypertension.
    • To evaluate the single and repeat dose pharmacokinetic profile of SLx-2101 and its M1 metabolite, SLx-2081, in hypertensive patients.
    • To determine the safety and tolerability of repeat oral doses of SLx-2101 5 mg or 10 mg for 14 days in patients with hypertension.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects aged between 18 and 70 years, inclusive.
    -Female subjects of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy, double oophorectomy or tubal ligation or postmenopausal defined as 12 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/mL and oestradiol levels < 30 pg/mL or
    − Females, who are of childbearing potential, must use adequate contraception with
    double protection prior to and during the trial: double barrier methods (condom,
    diaphragm, coil or intrauterine device (IUD,) in combination with spermicide) or
    hormonal contraception (oral, depot or implants) in combination with a barrier
    method.
    2. Moderate to severe hypertension, defined as a DBP of >90 mmHg and <110 mmHg
    and a sustained SBP of >140 mmHg and < 180 mmHg or a sustained SBP of >140
    mmHg and < 180 mmHg (ISH).
    (In case of subject receiving antihypertensive agents a DBP ³85 mmHg and £110 mmHg
    and a sustained SBP of ³130 mmHg and £180 mmHg or a sustained SBP of ³130
    mmHg and £ 180 mmHg will be acceptable).
    3. Body weight within a body mass index range of 18 – 32 kg/m2.
    4. Able to provide written informed consent prior to the performance of any study
    specific procedures.
    5. A 12-lead ECG at the pre-study medical, which in the opinion of the Investigator, has
    no abnormalities that will compromise safety in this study.
    6. A negative pre-study urine drugs of abuse screen within 21 days of study start.
    7. Available to complete all study measurements.
    E.4Principal exclusion criteria
    1. Past or present disease that is judged by the Investigator to have the potential to
    interfere with the study procedures, compromise safety, or affect the pharmacodynamic evaluations.
    2. The subject has a history of orthostatic hypotension, fainting spells or blackouts.
    3. The subject is taking nitrates and/or alpha-blockers or medication known to affect
    BP except those allowed in the protocol, please refer to Section 4.2.4 for permitted
    and prohibited drugs)..
    4. The subject has been a regular user of PDE-5 inhibitors and/or is unable to refrain
    from using these agents for 5 days before and for the period of their participation in
    the study.
    5. The subject is receiving more than THREE antihypertensive agents.
    6. The subject has malignant hypertension, primary hyperaldosteronism or secondary
    hypertension.
    7. Screening liver function tests exceeding 1.5 times the upper limit of the normal
    range.
    8. Active pancreatitis.
    9. Abuse of alcohol, defined as a average weekly intake of greater than 21 units for
    males or 14 units for females (1 unit is equivalent to a half pint of beer or 1 measure
    of spirits or 1 glass of wine).
    10. A history of drug abuse.
    11. History or presence of gastro-intestinal, hepatic or renal disease or other condition
    known to interfere with the absorption, distribution, metabolism or excretion of
    drugs.
    12. History or presence of severe peripheral vascular disease, coronary heart disease,
    heart failure (New York Heart Association type II, III or IV), myocardial infarction
    or cardiac surgery (in the last 12 months), hypertrophic obstructive cardiomyopathy,
    aortic or mitral valve stenosis, stroke, PCTA in the last 6 months.
    13. Known to be infected with the human immunodeficiency virus or hepatitis B or C.
    14. The subject has an abnormal thyroid function test assessed by thyroid stimulating
    hormone (TSH) levels at Screening.
    15. Exposure to a new chemical entity within 3 months prior to the first dosing day.
    16. Participation in a trial with any drug within 30 days before the start of the study.
    17. The subject has a known significant history of non-compliance with prescribed
    medication.
    18. If participation in the study will result in the volunteer having donated more than
    500 mL blood (males) in the previous 6 months.
    19. Male subjects attempting to father a child during and up to 3 months after the study
    Female subjects attempting to become pregnant during and up to 3 months after the
    study.
    20. If in the Investigators opinion, the subject is unsuitable to participate in the study.
    21. Inability to understand the protocol requirements, instructions and study-related
    restrictions; the nature, scope and possible consequences of the study.
    22. Unlikely to complete the study; e.g., uncooperative attitude, inability to return for
    Follow-up Visits.
    23. Subject is the Investigator or any sub-investigator, research assistant, pharmacist,
    study coordinator, other staff, or relative thereof directly involved in the conduct of
    the study.
    24. Vulnerable individuals (e.g., persons kept in detention).
    E.5 End points
    E.5.1Primary end point(s)
    Placebo-corrected supine peripheral SBP, DBP and heart rate at 1, 2, 4, 6, 8, 12, 16
    and 24 h post-dose and 2-minute standing peripheral SBP, DBP and heart rate at 2, 4, 8, 12 and 24 h after SLx-2101 5 mg or 10 mg dosed once daily for 14 days.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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.8.3 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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 years0
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    Subjects will complete a follow-up assessment approximately 5 – 7 days following the final dose.
    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 Decision2007-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-12-07
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