Valsartan Intensified Primary Care Reduction of Blood Pressure Study

NCT ID: NCT00902304

Last Updated: 2012-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2337 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2011-07-31

Brief Summary

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

Conditions

Hypertension

Keywords

Hypertension; valsartan

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual care

Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: DRUG

As directed by investigator

Monotherapy (initial monotherapy arm)

Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.

Group Type: EXPERIMENTAL

Valsartan and hydrochlorothiazide (HCTZ) - monotherapy

Intervention Type: DRUG

Monotherapy arm - if monotherapy valsartan 320mg per day orally was not sufficient, then could add HCTZ up to 25 mg per day orally

Valsartan

Intervention Type: DRUG

Valsartan 160mg per day to 320mg per day orally

Combination (initial combination therapy arm)

Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.

Group Type: EXPERIMENTAL

Valsartan and amlodipine

Intervention Type: DRUG

From valsartan 80mg/amlodipine 5mg per day to valsartan 160mg/amlodipine 10mg per day orally

Valsartan and hydrochlorothiazide (HCTZ) - combination arm

Intervention Type: DRUG

Combination arm - from valsartan 80mg/hydrochlorothiazide 12.5mg per day to valsartan 160mg/hydrochlorothiazide 25mg per day orally

Interventions

Valsartan and hydrochlorothiazide (HCTZ) - monotherapy

Monotherapy arm - if monotherapy valsartan 320mg per day orally was not sufficient, then could add HCTZ up to 25 mg per day orally

Intervention Type: DRUG

Valsartan and amlodipine

From valsartan 80mg/amlodipine 5mg per day to valsartan 160mg/amlodipine 10mg per day orally

Intervention Type: DRUG

Usual care

As directed by investigator

Intervention Type: DRUG

Valsartan

Valsartan 160mg per day to 320mg per day orally

Intervention Type: DRUG

Valsartan and hydrochlorothiazide (HCTZ) - combination arm

Combination arm - from valsartan 80mg/hydrochlorothiazide 12.5mg per day to valsartan 160mg/hydrochlorothiazide 25mg per day orally

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baker Heart and Diabetes Institute

OTHER

Sponsor Role: collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Professor Garry Jennings-Co Principal Investigator

Melbourne, , Australia

Professor Simon Stewart-Principal Investigator

Melbourne, , Australia

Countries

United States; Australia

Other Identifiers

CVAL489AAU01

Identifier Type: -

Identifier Source: org_study_id