The Effects of Moderate vs. Aggressive Treatment With Valsartan + Amlodipine on Patients With Hypertension Uncontrolled by Angiotensin-Receptor Blocker (Herein, ARB) Monotherapy

NCT00666536 | Completed Phase 4 Results

• 1 other identifier: CVAA489AUS02
• Study Type: interventional
• Target: 728
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to compare blood pressure lowering efficacy of moderate Valsartan + Amlodipine treatment regimen (160 / 5 mg) with that of aggressive regimen (320 / 10 mg) in patients uncontrolled on ARB monotherapy, other than Valsartan

Conditions

Hypertension

Keywords

Hypertension; adults; Valsartan + Amlodipine; Angiotensin Receptor Blockers

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)

  Baseline and Week 4

Secondary Outcomes (5)

• Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12

  Weeks 2, 4, 8 and 12

• Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)

  Baseline and Week 4

• Change From Baseline to Weeks 2, 8 and 12 in MSSBP

  Baseline and Weeks 2, 8 and 12

• Change From Baseline to Weeks 2, 8 and 12 in MSDBP

  Baseline and Weeks 2, 8 and 12

• Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12

  Weeks 2, 4, 8 and 12

Study Arms (2)

Aggressive treatment regimen (5/320 mg to 10/320 mg)

ACTIVE COMPARATOR

Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)

Drug: valsartan and amlodipine

Moderate treatment regimen (5/160 mg)

ACTIVE COMPARATOR

Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)

Drug: valsartan and amlodipine

Interventions

valsartan and amlodipine DRUG

Aggressive treatment regimen (5/320 mg to 10/320 mg)

Eligibility Criteria

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

You may qualify if:

• Male and female outpatients
• Years of age or older
• Mean Sitting Systolic Blood Pressure (the top number) greater than or equal to 150 mmHg and lower than 200 mmHg while on Angiotensin-Receptor Blocker monotherapy for a minimum period of 28 days prior to randomization

You may not qualify if:

• Mean Sitting Systolic Blood Pressure (the top number) greater than or equal to 200 mmHg and/or Mean Sitting Diastolic Blood Pressure greater than or equal to 120 mmHg
• Transient ischemic attack (mini-stroke), myocardial infarction (heart attack), all types of revascularization procedures in the last 6 months
• Treatment with valsartan or any combination antihypertensive treatment with 28 days prior to screening (Visit 1)

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Egan Healthcare

Metairie, Louisiana, 70002, United States

Location

Related Publications (2)

• Oparil S, Giles T, Ofili EO, Pitt B, Seifu Y, Hilkert R, Samuel R, Sowers JR. Moderate versus intensive treatment of hypertension with amlodipine/valsartan for patients uncontrolled on angiotensin receptor blocker monotherapy. J Hypertens. 2011 Jan;29(1):161-70. doi: 10.1097/HJH.0b013e32834000a7.

  PMID: 21045734 RESULT

• Giles TD, Oparil S, Ofili EO, Pitt B, Purkayastha D, Hilkert R, Samuel R, Sowers JR. The role of ambulatory blood pressure monitoring compared with clinic and home blood pressure measures in evaluating moderate versus intensive treatment of hypertension with amlodipine/valsartan for patients uncontrolled on angiotensin receptor blocker monotherapy. Blood Press Monit. 2011 Apr;16(2):87-95. doi: 10.1097/MBP.0b013e328344c713.

  PMID: 21386706 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine, Valsartan Drug Combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Valsartan; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amlodipine; Dihydropyridines; Pyridines; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Suzanne Oparil, MD et al

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 23, 2008
• First Posted: April 25, 2008
• Study Start: March 1, 2008
• Primary Completion: January 1, 2009
• Last Updated: October 27, 2016
• Results First Posted: December 10, 2010

Record last verified: 2011-04

Locations

US (1)