The Efficacy and Safety of Irbesartan 150/12.5 mg and 300/25 mg in Patients With Mild Hypertension
Phase 4
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00562809
- Lead Sponsor
- Sanofi
- Brief Summary
The purpose of this study is to assess the efficacy and safety of Irbesartan 150/12.5 mg and 300/25 mg in patients with hypertension not controlled by monotherapy.
- Detailed Description
The primary and secondary endpoints applied to sub-groups defined by age, race, diabetes, metabolic syndrome and prior HTN therapy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1005
Inclusion Criteria
- The patient must have hypertension and uncontrolled SBP on monotherapy.
- Patients who have read, signed and received a copy of the informed consent prior to any study procedures
Note: Female patients must be post-menopausal for one year, surgically sterilized, or using a medically accepted method of contraception (intrauterine device, oral contraceptives, barrier method with spermicide) and must agree to use an effective method of contraception throughout the study.
Exclusion Criteria
- Any history of secondary hypertension
- History of hypertensive encephalopathy, stroke, or transient ischemic attack (TIA) within the past 12 months
- History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in the mean SBP from baseline to week 18
- Secondary Outcome Measures
Name Time Method Change in mean DBP from baseline to week 18. Changes in mean SBP and DBP from baseline to week 10 SBP and DBP response and control rates at weeks 10 and 18
Trial Locations
- Locations (1)
Sanofi-Aventis
🇺🇸Bridgewater, New Jersey, United States