Status:
COMPLETED
AVE7688 in Patients With Mild to Moderate Blood Pressure
Lead Sponsor:
Sanofi
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 obje...
Detailed Description
This study is a prospective multi-center, randomized, double-blind, active-controlled parallel-group, dose ranging study with 5 treatment groups (AVE7688 at 4 different dosages, and losartan-potassium...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
1940 Patients enrolled
Trial Details
Trial ID
NCT00284128
Start Date
December 1 2005
End Date
March 1 2008
Last Update
May 18 2016
Active Locations (21)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
3
Sanofi-Aventis Administrative Office
São Paulo, Brazil
4
Sanofi-Aventis Administrative Office
Laval, Canada