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    Summary
    EudraCT Number:2005-003521-13
    Sponsor's Protocol Code Number:DFI6032
    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:2006-03-22
    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 ConcernedGermany - BfArM
    A.2EudraCT number2005-003521-13
    A.3Full title of the trial
    Double-blind, randomized, parallel-group, dose ranging, multi-center study to evaluate the efficacy and safety of 2.5, 10, 35 and 50 mg AVE7688 once daily, using 100 mg losartan-potassium once daily as calibrator, for 12 months treatment, in patients with mild to moderate hypertension
    A.3.2Name or abbreviated title of the trial where available
    RAVEL-1
    A.4.1Sponsor's protocol code numberDFI6032
    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 SponsorAventis Pharmaceuticals 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 AVE7688
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.9.1CAS number 473289-62-2
    D.3.9.2Current sponsor codeAVE7688
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number2.5; 10; 25 to and 50
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name LORZAAR
    D.2.1.1.2Name of the Marketing Authorisation holderMSD CHIBROPHARM GMBH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameLORZAAR (sourced from Germany)
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.8INN - Proposed INNlosartan potassium
    D.3.9.1CAS number 124750-99-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Mild to moderate 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
    The primary objective of the study is to assess the efficacy of 2.5, 10, 35 and 50 mg AVE 7688 once daily on the change from baseline in trough seated diastolic blood pressure (SeDBP) , at the end of 12 weeks of treatment in patients with mild to moderate essential hypertension.
    E.2.2Secondary objectives of the trial
    The secondary objectives, in order of importance, are:
    - To assess the efficacy of 2.5, 10, 35 and 50 mg AVE 7688 once daily on the change from baseline in trough seated systolic blood Pressure (SeSBP) at the end of 12 weeks of treatment.
    - To compare the percentages of responders after 12 weeks of treatment.
    - To evaluate the long-term safety and tolerability of AVE7688 at doses of 2.5, 10, 35 or 50 mg, with particular attention to angioedema.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patients, 18 years of age or older, with mild-to-moderate, treated or untreated, essential hypertension, as defined by the JNC VII guidelines, who meet the following BP eligibility criteria:
    - At the first qualifying visit in the placebo lead-in phase (either visit P2 or P3), mean SeSBP ≥140 mm Hg and <180 mm Hg and mean SeDBP ≥90 mm Hg and <110 mm Hg (mean of at least 3 readings)
    - At the second qualifying visit in the placebo lead-in phase (either visit P3 or P4 separated from the first qualifying visit by at least 1 week), SeSBP ≥140 mm Hg and <180 mm Hg and mean SeDBP ≥90 mm Hg and <110 mm Hg (mean of at least 3 readings). If the patient does not meet the criteria at the second qualifying visit, he or she will be excluded from randomization.
    - The patient can be included in the study only when the variability between the mean BP measurements on the two consecutive qualifying visits (either P2 and P3 or P3 and P4 (if applicable)) is less or equal than 7 mm Hg for SeDBP.
    E.4Principal exclusion criteria
    Criteria related to study methodology:
    - Refusal or inability to give informed consent
    - Patients who have previously been treated with AVE7688
    - Patients who cannot stop their anti-hypertensive treatment (e.g., ACE-I (angiotensin convertin enzyme inhibitor), ARB (angiotensin receptor blocker), CCB (calcium channel blocker), diuretics, AB (alpha blocker), BB (beta blocker), Hydralazine, Rauwolfia alkaloids
    - Known history of secondary hypertension, including patients with endocrine disorders such as pheochromocytoma, active hyperthyroidism, or untreated hypothyroidism
    - Severe hypertension, defined as SeSBP ≥180 mm Hg or SeDBP ≥110 mm Hg
    - Women of child bearing potential (i.e. female patients who are not postmenopausal or surgically sterile), who have a positive serum pregnancy test, or who do not agree to use an accepted method of contraception
    - Women who are breast feeding
    - Patients with non-cardiac progressive fatal disease
    - Patients with immunological or hematological disorders
    - Requirement for concomitant treatment that could bias the primary evaluation, e.g. long-term treatment with anti-psychotic compounds or long-term steroid use
    - Unstable insulin-dependent diabetes mellitus
    - History of stroke, intracranial hemorrhage or transitory ischemic attack within the previous year
    - Likelihood of poor compliance both with treatment and study design, including social and geographical reasons
    - Patient is the investigator, sub-investigator, research assistant, pharmacist, study coordinator, or other staff member or relative thereof directly involved in the conduct of the study
    - Administration of any investigational drug within the preceding 30 days. Investigational drug is defined as any agent (placebo or active drug) dispensed as part of a research study
    - Abuse of drugs or alcoholic beverages within 1 year prior to the start of the study
    - Patients taking herbal or dietary compounds that have the potential to influence blood pressure

    Criteria related to ACE-inhibition
    - Contraindications to losartan-potassium as per local package insert
    - History of hypersensitivity or angioedema with ACE inhibitors or NEP inhibitors, patients with hereditary or idiopathic angioedema, patients with allergic reaction in which urticaria or angioedema was the manifestation
    - Impaired hepatic function (i.e., AST and/or ALT >1.5 x upper limit of normal range)
    - Known unilateral or bilateral renal artery stenosis
    - Serum potassium ≥ 5.5 mmol/L
    - Impaired renal function (i.e. calculated creatinine clearance < 50 ml/min)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change from baseline in trough SeDBP at week 12.

    The secondary efficacy endpoints, in a hierarchical order, are:
    - The change from baseline in trough SeSBP at week 12
    - The percentage of responders in each treatment group at week 12, where responders are defined as follows:
    . Patients with BP ≤140/90 mm Hg after 12 weeks, or
    . Patients with a reduction from baseline in SeDBP of ≥10 mm Hg or in SeSBP of ≥20 mm Hg
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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) Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    losartan potassium (as calibrator)
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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 years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state95
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 1730
    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 Decision2006-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-04-03
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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