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

Novartis488 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

488

Conditions

Stage 2 Systolic Hypertension

Interventions

valsartan, amlodipine, HCTZDRUG

combination Valsartan/amlodipine160/5 mg tablet for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (6 weeks) of the study

Losartan, HCTZ followed by valsartan, amlodipine, HCTZDRUG

losartan 100mg capsule for 3 weeks; losartan 100mg capsule +HCTZ 25 mg capsule for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (3 weeks) of the study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

sites in USA

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Change in Mean Sitting Systolic Blood Pressure After 6 Weeks

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.

Time frame: Baseline to Week 6

Secondary Outcomes

Change in Mean Sitting Diastolic Blood Pressure After 6 Weeks

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.

Time frame: Baseline to Week 6

Cumulative Percentage of Patients Achieving Blood Pressure Control

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.

Time frame: 3 and 6 weeks

Cumulative Percentage of Treatment Responders

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.

Time frame: 3 and 6 weeks

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

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.

Time frame: Baseline to week 12

Data from ClinicalTrials.gov

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