Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension

Phase 4

Completed

• Conditions: Stage 2 Systolic Hypertension
• Interventions: Drug: valsartan, amlodipine, HCTZ; Drug: Losartan, HCTZ followed by valsartan, amlodipine, HCTZ

• Registration Number: NCT00931710
• Lead Sponsor: Novartis

Brief Summary

This study will compare the antihypertensive efficacy and safety of a valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2 systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and less than 200 mmHg).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-01
• Study First Submitted QC: 2009-07-01
• Study First Posted: 2009-07-02
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Results First Submitted: 2011-01-13
• Results First Submitted QC: 2011-01-13
• Results First Posted: 2011-02-04
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-01
• Last Update Posted: 2011-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 488

Inclusion Criteria

• Male or female outpatient of 18 years of age or greater
• Stage 2 systolic hypertension defined as office Mean Sitting Systolic blood pressure (MSSBP) greater than or equal to 160 and < 200 mmHg at randomization
• Patients who were able to participate in the study, and who gave written informed consent before any study assessment was performed.

Exclusion Criteria

• Office systolic blood pressure >200 and/or mean sitting diastolic blood pressure (MSDBP) greater than or equal to 110 mmHg at Visit 1.
• Use of four (4) or more antihypertensive medications within 30 days of Visit 1.
• Refractory hypertension, defined as blood pressure >140/90 mmHg while taking three (3) drugs at the maximum dose of each drug, one of which must be a diuretic. (Therapy with a fixed-dose combination of two active medications represents two drugs).
• Inability to safely discontinue all antihypertensive medications for 1-2 weeks prior to randomization.

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Valsartan/amlodipine/HCTZ	valsartan, amlodipine, HCTZ	Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
Losartan/HCTZ	Losartan, HCTZ followed by valsartan, amlodipine, HCTZ	Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.

Primary Outcome Measures

Name	Time	Method
Change in Mean Sitting Systolic Blood Pressure After 6 Weeks	Baseline to Week 6	To compare the change from baseline in mean sitting systolic blood pressure (MSSBP) after 6 weeks of valsartan/amlodipine-based regimen with a losartan-based regimen in patients with Stage 2 systolic hypertension.

Secondary Outcome Measures

Name	Time	Method
Change in Mean Sitting Diastolic Blood Pressure After 6 Weeks	Baseline to Week 6	To compare the change from baseline in mean sitting diastolic blood pressure (MSDBP) after 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.
Cumulative Percentage of Patients Achieving Blood Pressure Control	3 and 6 weeks	To compare the percentage of patients achieving blood pressure control (defined as patients achieving MSSBP \< 140 mmHg and MSDBP \< 90 mmHg) after 3 and 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.
Cumulative Percentage of Treatment Responders	3 and 6 weeks	To compare the percentage of treatment responders (defined as patients with MSSBP \< 140 mmHg or demonstrating a decrease from baseline of ≥ 20 mmHg) after 3 and 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.
Change in Mean Sitting Systolic and Diastolic Blood Pressure After 12 Weeks	Baseline to week 12	To compare the change from baseline in MSSBP and MSDBP after 12 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.
Cumulative Percentage of Patients With Incidence of Peripheral Edema Before or at the Corresponding Visit	3, 6, 9 and 12 weeks	To assess the incidence of peripheral edema occurring with valsartan/amlodipine-based regimen versus losartan-based regimen in patients with Stage 2 systolic hypertension.

Trial Locations

Locations (1)

sites in USA; 🇺🇸 East Hanover, New Jersey, United States