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. - ND

• Conditions: MILD TO MODERARATE HYPERTENSION; MedDRA version: 6.1Level: PTClassification code 10015488

• Registration Number: EUCTR2005-003521-13-IT
• Lead Sponsor: Aventis Pharma Recherche De ve loppement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1730

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 two weeks after the start of the leading phase , 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 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 inclusion criteria at the second qualifying visit, a third qualifying visit one additional week later will be performed. If the patient does not meet the criteria at the third qualifying visit, he or she will not be qualified for randomization. - If the variability between the mean BP measurements on the 2 qualifying visits is more than 7 mm Hg for SeDBP, the patient will be excluded from the study
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 - 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, medical history of allergy or asthma - 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified