Efficacy and Safety of Valsartan/Amlodipine Combination in Hypertensive Patients Not Controlled With Valsartan Alone

Condition(s) targeted: Hypertension

Intervention: valsartan/amlodipine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

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

This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication

Official title: Valsartan/Amlodipine 160/5 mg or 160/10 mg Versus Valsartan 160 mg Alone for 8 Weeks in Hypertensive Patients Who Are Not Adequately Controlled on Valsartan 160 mg Monotherapy

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

Primary outcome: Change from baseline in diastolic blood pressure after 8 weeks

Secondary outcome:

Change from baseline in mean systolic blood pressure after 8 weeks

Decrease in diastolic blood pressure of at least 10 mmHg or diastolic blood pressure was less than 90 mmHg after 8 weeks

Diastolic blood pressure less than 90 mmHg after 8 weeks

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with uncomplicated, essential hypertension

Exclusion Criteria:

- Severe hypertension

- History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart

rhythm

- Liver, kidney, or pancreas disease

- Insulin dependent diabetes

- Allergy to certain medications used to treat high blood pressure

Other protocol-defined exclusion criteria may apply.

Investigative Centers, Germany

Novartis Pharmaceuticals, Basel, Switzerland

Starting date: October 2004
Last updated: November 13, 2006