A Study to Evaluate the Combination of Valsartan + Amlodipine in Hypertensive Patients

Novartis224 enrolled

Overview

The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with amlodipine or felodipine alone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

224

Conditions

Hypertension

Interventions

valsartan + amlodipineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female patients (18 years) 2. Patients with moderate essential hypertension (untreated must have MSSBP ≥160 and \<180 mmHg at Visit 1, treated must have MSSBP \<180 mmHg at Visit 1) (WHO grade II) Exclusion Criteria: 1. Severe hypertension(MSDBP ≥110 mmHg or MSSBP ≥ 180 mmHg) 2. Pregnant or nursing women 3. Treated hypertensive patients with controlled hypertension under current therapy (diastolic BP \< 90 mmHg and systolic BP \< 140 mmHg) 4. A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV Other protocol-defined inclusion/exclusion criteria may apply.

Locations (2)

Unnamed facility

Investigative Centers, Germany

Novartis

Basel, Switzerland

Outcomes

Primary Outcomes

To investigate whether 4 weeks treatment with valsartan 160mg + amlo 5mg provide an add'l mean sitting systolic blood pressure reduction in patients not adequately responding to 4 weeks treatment with amlo 5mg or felodipine 5mg

Secondary Outcomes

Mean sitting diastolic blood pressure (analogously & explorative)

Normalization (analogously & explorative)

Responder rate. (analogously & explorative)

Data from ClinicalTrials.gov

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