Valsartan Intensified Primary Care Reduction of Blood Pressure Study (VIPER-BP)

Novartis

Status and phase: Completed; Phase 4

Conditions: Hypertension

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00902304

CVAL489AAU01

Details and patient eligibility

About

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

Enrollment: 2,337 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,337 participants in 3 patient groups

Usual care

Active Comparator group

Description:

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

Treatment:

Drug: Usual care

Monotherapy (initial monotherapy arm)

Experimental group

Description:

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.

Treatment:

Drug: Valsartan

Drug: Valsartan and hydrochlorothiazide (HCTZ) - monotherapy

Combination (initial combination therapy arm)

Experimental group

Description:

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.

Treatment:

Drug: Valsartan and hydrochlorothiazide (HCTZ) - combination arm

Drug: Valsartan and amlodipine