Overview

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

Status:
Completed
Trial end date:
2007-01-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Novartis
Treatments:
Amlodipine
Valsartan
Criteria
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