A Dose response study in patients with mild to moderate hypertension.
- Conditions
- Health Condition 1: null- Systolic Hypertension
- Registration Number
- CTRI/2011/04/001682
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 910
1. Severe hypertension
2. Written informed consent must be obtained before any assessment is performed. Patients with mild-to-moderate systolic hypertension, untreated or currently taking antihypertensive therapy.
3. Ability to communicate and comply with all study requirements and demonstrate good medication compliance ( greater than or equal to 80 percent compliance rate) during the run-in period.
1. History of angioedema, drug-related or otherwise, as reported by the patient.
2. Pregnant or nursing (lactating) women.
3. Women of child-bearing potential (WOCBP), UNLESS they are using adequate birth control methods.
4. History or evidence of a secondary form of hypertension.
5. Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method reduction in mean sitting systolic blood pressure (msSBP)Timepoint: Baseline and 8 weeks
- Secondary Outcome Measures
Name Time Method changes in mean 24 hour ambulatory SBP (maSBP), mean 24 hour ambulatory DBP (maDBP), daytime and nighttime msSBP/maDBP of ascending doses of AHU377 in combination with valsartan 320mg as compared to valsartan 320mg monotherapyTimepoint: Baseline and 8 weeks;dose-response relationship in msSBP/msDBP and maSBP/maDBP lowering of ascending doses of AHU377 in combination with valsartan 320mg by sub-group analysis of age ( less than 65 and greater than or equal to 65)Timepoint: Baseline and 8 weeks;dose-response relationship in sitting diastolic blood pressure (msDBP) lowering of ascending doses of AHU377 in combination with valsartan 320 mgTimepoint: Baseline and 8 weeks;Frequency of adverse events, serious adverse events, and notable laboratory abnormalitiesTimepoint: Baseline and 8 weeks;office and ambulatory pulse pressure for all treatment groupsTimepoint: Baseline and 8 weeks