Valsartan Intensified Primary Care Reduction of Blood Pressure Study

NCT00902304 | Completed Phase 4 Results

• 1 other identifier: CVAL489AAU01
• Study Type: interventional
• Target: 2,337
• Locations: 2 countries
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

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

  BP target groups were: \<= 125/75mmHg, \<= 130/80mmHg and \<= 140/90mmHg. The BP target was based on the patient's clinical risk profile as specified by National Heart Foundation of Australia guidelines.

  26 weeks

Secondary Outcomes (12)

• Change in Mean Sitting Systolic Blood Pressure

  Baseline and 26 weeks

• Change in Mean Sitting Diastolic Blood Pressure

  Baseline and 26 weeks

• Change in Absolute Cardiovascular Risk Score

  Baseline and 26 weeks

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

  26 weeks

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

  26 weeks

Study Arms (3)

Usual care

ACTIVE COMPARATOR

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

Drug: Usual care

Monotherapy (initial monotherapy arm)

EXPERIMENTAL

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.

Drug: Valsartan and hydrochlorothiazide (HCTZ) - monotherapy; Drug: Valsartan

Combination (initial combination therapy arm)

EXPERIMENTAL

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.

Drug: Valsartan and amlodipine; Drug: Valsartan and hydrochlorothiazide (HCTZ) - combination arm

Interventions

Valsartan and hydrochlorothiazide (HCTZ) - monotherapy DRUG

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

Monotherapy (initial monotherapy arm)

Valsartan and amlodipine DRUG

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

Combination (initial combination therapy arm)

Usual care DRUG

As directed by investigator

Usual care

Valsartan DRUG

Valsartan 160mg per day to 320mg per day orally

Monotherapy (initial monotherapy arm)

Valsartan and hydrochlorothiazide (HCTZ) - combination arm DRUG

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

Combination (initial combination therapy arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead
• Baker Heart and Diabetes Institute: collaborator

Study Sites (3)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

Professor Garry Jennings-Co Principal Investigator

Melbourne, Australia

Location

Professor Simon Stewart-Principal Investigator

Melbourne, Australia

Location

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan; Hydrochlorothiazide; Amlodipine, Valsartan Drug Combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amlodipine; Dihydropyridines; Pyridines; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Study Director

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2009
• First Posted: May 15, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: December 4, 2012
• Results First Posted: August 30, 2012

Record last verified: 2012-11

Locations

US (1); AU (2)