AVE7688 in Patients With Mild to Moderate Blood Pressure

Completed · Phase 2/Phase 3

Conditions studied: Hypertension

In brief

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

Key facts

Study ID

NCT00284128

Run by

Sanofi

People needed

1940

Starts

2005-12-01

Expected to finish

2008-03-01

Last updated by the study team

2016-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — Buenos Aires, Argentina
• Sanofi-Aventis Administrative Office — São Paulo, Brazil
• Sanofi-Aventis Administrative Office — Laval, Canada
• Sanofi-Aventis Administrative Office — Santiago, Chile
• Sanofi-Aventis Administrative Office — Berlin, Germany
• Sanofi-Aventis Administrative Office — Athens, Greece
• Sanofi-Aventis Administrative Office — Causeway Bay, Hong Kong
• Sanofi-Aventis Administrative Office — Milan, Italy
• Sanofi-Aventis Administrative Office — Kuala Lumpur, Malaysia
• Sanofi-Aventis Administrative Office — México, Mexico
• Sanofi-Aventis Administrative Office — Gouda, Netherlands
• Sanofi-Aventis Administrative Office — Warsaw, Poland
• Sanofi-Aventis Administrative Office — Porto Salvo, Portugal
• Sanofi-Aventis Administrative Office — Moscow, Russia
• Sanofi-Aventis Administrative Office — Singapore, Singapore
• Sanofi-Aventis Administrative Office — Midrand, South Africa
• Sanofi-Aventis Administrative Office — Seoul, South Korea
• Sanofi-Aventis Administrative Office — Barcelona, Spain
• Sanofi-Aventis Administrative Office — Taipei, Taiwan
• Sanofi-Aventis Administrative Office — Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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