Valsartan Intensified Primary Care Reduction of Blood Pressure Study

Condition(s) targeted: Hypertension

Intervention: Valsartan and hydrochlorothiazide (HCTZ) - monotherapy (Drug); Valsartan and amlodipine (Drug); Usual care (Drug); Valsartan (Drug); Valsartan and hydrochlorothiazide (HCTZ) - combination arm (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis Pharmaceuticals

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

This study will assess the efficacy of an intensive blood pressure management strategy compared to usual care in a primary care (general practice) setting.

Official title: A Phase IV Clinical Trial of Intensified Blood Pressure Management in Primary Care Using Valsartan Alone and as Combination Anti-Hypertensive Therapy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target

Secondary outcome:

Change in Mean Sitting Systolic Blood Pressure

Change in Mean Sitting Diastolic Blood Pressure

Change in Absolute Cardiovascular Risk Score

Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy

Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments

Change in the EQ-5D Score

Number of Patients With Depression

Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26

Participants With End Organ Disease at Baseline and Week 26

Change in Self-care Behavior Score From Baseline to Week 26

Rate of Treatment Compliance

Number of Patients With Major Clinical Endpoints

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

Criteria:

Inclusion Criteria:

- newly diagnosed or currently treated hypertensive patients who have not attained

their blood pressure target and require active pharmacological treatment as recommended by the local guidelines as judged by the general practitioner Exclusion Criteria:

- significantly elevated blood pressure (severe hypertension)

- requiring 3 or more antihypertensive drugs

- severe kidney disease or dialyses

- clinical diagnosis requiring concomitant therapy with antihypertensive treatment that

would be outside the therapies allowed under study protocol Other protocol-defined inclusion/exclusion criteria may apply

Professor Garry Jennings-Co Principal Investigator, Melbourne, Australia

Professor Simon Stewart-Principal Investigator, Melbourne, Australia

Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States

Starting date: July 2009
Last updated: November 30, 2012