A Study to Evaluate the Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled on Monotherapy

Condition(s) targeted: Hypertension

Intervention: valsartan (Drug); hydrochlorothiazide (Drug); amlodipine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

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

This study is designed to provide additional efficacy and safety data for a treatment strategy based on the combination valsartan with amlodipine in hypertensive patients previously treated with monotherapy and remaining uncontrolled. A naturalistic approach will be taken comparing two different doses, i. e. 160mg of valsartan with amlodipine 5mg and 10mg with possible addition of HCTZ

Official title: A Double-Blind, Randomized, Multicenter Study to Evaluate the Effectiveness of the Combination of Valsartan & Amlodipine in Hypertensive Patients Not Controlled on Monotherapy

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

Primary outcome: Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 16 weeks

Secondary outcome:

Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 8 weeks.

Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 4, 12, and 16 weeks.

Change from baseline diastolic and systolic blood pressure measurements after 4, 8, 12, and 16 weeks

Diastolic blood pressure less than 90 mmHg in non-diabetic patients and diastolic blood pressure less than 80 mmHg in diabetic patients after 4, 8, 12, and 16 weeks

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

Criteria:

Inclusion criteria

- Male or female patients ≥18 years of age

- Non-diabetic patients must have MSSBP of ≥140 mmHg and/or MSDBP ≥90 mmHg at Visits 1

and 2. Diabetic patients must have MSSBP ≥130 mmHg and/or MSDBP ≥80 mmHg at Visits 1 and 2

- Patients treated with monotherapy at a dose considered as adequate by the investigator

for a minimum of two months prior to Visit 1

Exclusion criteria

- Known or suspected contraindications, including history of allergy to ARBs, CCB,

thiazides or to drugs with similar chemical structure.

- MSSBP ≥180 mmHg and/or MSDBP ≥110 mmHg (MSSBP ≥160 mmHg and/or MSDBP ≥100 mmHg for

diabetic patients) at any time between Visit 1 and Visit 2.

- Evidence of a secondary form of hypertension, to include coarctation of the aorta,

primary hyperaldosteronism, renal artery stenosis, or pheochromocytoma.

- Known Keith-Wagener grade III or IV hypertensive retinopathy.

- Other exclusion criteria apply

Novartis Pharmaceuticals, Basel, Switzerland

Novartis patient recruitment site

Starting date: March 2006
Ending date: February 2007
Last updated: February 28, 2007