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

Condition(s) targeted: Stage 2 Systolic Hypertension

Intervention: valsartan, amlodipine, HCTZ (Drug); Losartan, HCTZ followed by valsartan, amlodipine, HCTZ (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: 862-778-8300

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).

Official title: A 12-week Multicenter, Randomized, Double-blind, Parallel-group, Active-control Study to Evaluate the Antihypertensive Efficacy and Safety of Valsartan/Amlodipine-based Regimen Versus a Losartan-based Regimen in Patients With Stage 2 Systolic Hypertension

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change in Mean Sitting Systolic Blood Pressure After 6 Weeks

Secondary outcome:

Change in Mean Sitting Diastolic Blood Pressure After 6 Weeks

Cumulative Percentage of Patients Achieving Blood Pressure Control

Cumulative Percentage of Treatment Responders

Change in Mean Sitting Systolic and Diastolic Blood Pressure After 12 Weeks

Cumulative Percentage of Patients With Incidence of Peripheral Edema Before or at the Corresponding Visit

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

sites in USA, East Hanover, New Jersey, United States

Starting date: July 2009
Last updated: March 1, 2011