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

Condition(s) targeted: Hypertension

Intervention: valsartan (Drug); amlodipine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novatis Pharmaceuticals

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.

Official title: A 14 Week Study to Evaluate Effectiveness of a Valsartan Versus an Amlodipine Treatment Strategy in Achieving Blood Pressure Control in Patients With Stage 1 or Stage 2 Hypertension or Uncontrolled on Present Monotherapy

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Blood pressure less than 140/90 mmHg after 14 weeks

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Investigative Centers, Germany

Novartis Pharmaceuticals, Basel, Switzerland

Last updated: August 13, 2007