AVE7688 in Patients With Mild to Moderate Blood Pressure

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to assess the antihypertensive efficacy of 4 different AVE 7688 doses on the change from baseline in trough diastolic blood pressure at the end of week 12.

The secondary objectives are:

• To assess the antihypertensive efficacy of 4 different AVE 7688 doses on the change from baseline in trough systolic blood pressure at the end of week 12

• To compare the percentages of responders after 12 week of treatment

• To evaluate the long term safety and tolerability of AVE 7688 with particular attention to angioedema

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Losartan

Criteria

Inclusion Criteria:

• Patients with mild-to-moderate, treated or untreated, essential hypertension, as defined by the JNC VII (Joint National Committee on the Prevention, Detection, Evaluation, and

Treatment of High Blood Pressure, Seventh report ) guidelines who meet the following BP eligibility criteria:

• mean SeSBP (Seated systolic blood pressure) ≥140 mm Hg and <180 mm Hg and mean SeDBP (Seated diastolic blood pressure) ≥90 mm Hg and <110 mm Hg at two consecutive qualifying visits in the placebo lead-in phase

• variability between the mean BP measurements on the 2 consecutive qualifying visits is less or equal 7 mm Hg for SeDBP.

Exclusion Criteria:

• Refusal or inability to give informed consent

• Patients who have previously been treated with AVE7688

• Patients who cannot stop their anti-hypertensive treatment

• Known history of secondary hypertension, including patients with endocrine disorders such as pheochromocytoma, active hyperthyroidism, or untreated hypothyroidism

• Severe hypertension

• Women of child bearing potential, 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

• 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

• Patient is the investigator, sub-investigator, research assistant, pharmacist, study coordinator, or other staff member or relative there of directly involved in the conduct of the study

• Administration of any investigational drug within the preceding 30 days

• 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

• 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

• Known unilateral or bilateral renal artery stenosis

• Serum potassium > 5.5 mmol/L

• Impaired renal function