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Clinical Trials/EUCTR2005-003521-13-DE
EUCTR2005-003521-13-DE
Active, not recruiting
Not Applicable

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 - RAVEL-1

Aventis Pharmaceuticals Inc.0 sites1,730 target enrollmentMarch 22, 2006
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Aventis Pharmaceuticals Inc.
Enrollment
1730
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 22, 2006
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

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

Outcomes

Primary Outcomes

Not specified

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