Effectiveness of a Valsartan Based Versus an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy

Novartis1,288 enrolled

Overview

The population for this current study will include stage 1 and stage 2 hypertensive patients who are newly diagnosed or didn't have treatment during the last 3 months and patients who are currently treated but uncontrolled on present monotherapy. The purpose of this study is to evaluate the efficacy of a treatment with valsartan versus a treatment with amlodipine in reaching blood pressure control after 14 weeks of treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,288

Conditions

Hypertension

Interventions

valsartanDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria Stage/grade 1 or stage/ grade 2 hypertension, MSSBP ≥ 140 mm Hg, and/ or MSDBP ≥ 90 mm Hg, at Visit 1 and 2 in untreated patients Or Patients who are currently treated on monotherapy and uncontrolled and have a blood pressure ≤ 160/100 mm Hg at Visit 1 and Visit 2 Exclusion criteria Current treatment with a CCB MSSBP ≥ 180 mm Hg or MSDBP ≥ 110 mm Hg at any time between visit 1 and Visit 2 History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures Evidence of a secondary form of hypertension Cerebrovascular accident or myocardial infarction during the last 12 months, prior to Visit 1 Other protocol-defined inclusion/exclusion criteria may apply

Locations (2)

Unnamed facility

Investigative Centers, Germany

Novartis Pharmaceuticals

Basel, Switzerland

Outcomes

Primary Outcomes

Blood pressure less than 140/90 mmHg after 14 weeks

Secondary Outcomes

Blood pressure less than 140/90 mmHg after 4, 8, and 11 weeks

Blood pressure less than 140/90 mmHg after 4, 8, 11, and 14 weeks

Time when blood pressure reaches less than 140/90 mmHg

Change in blood pressure at baseline, week 4, 8, 11, and 14

Adverse events and serious adverse events at each study visit for 14 weeks