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

• ClinicalTrials.gov Identifier: NCT00666536
• Recruitment Status: Completed
• First Posted: April 25, 2008
• Results First Posted: December 10, 2010
• Last Update Posted: October 27, 2016
• Sponsor: Novartis
• Information provided by: Novartis

Study Description

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

Condition or disease	Intervention/treatment	Phase
Hypertension	Drug: valsartan and amlodipine	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 728 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double Blind, Parallel Design Trial to Evaluate the Blood Pressure Lowering Efficacy Comparing Moderate Versus Aggressive Treatment Regimen of Valsartan + Amlodipine in Patients Uncontrolled on ARB Monotherapy
• Study Start Date: March 2008
• Actual Primary Completion Date: January 2009

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Aggressive treatment regimen (5/320 mg to 10/320 mg); 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
Active Comparator: Moderate treatment regimen (5/160 mg); 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

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP) [ Time Frame: Baseline and Week 4 ]

Secondary Outcome Measures :

1. Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12 [ Time Frame: Weeks 2, 4, 8 and 12 ]
2. Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: Baseline and Week 4 ]
3. Change From Baseline to Weeks 2, 8 and 12 in MSSBP [ Time Frame: Baseline and Weeks 2, 8 and 12 ]
4. Change From Baseline to Weeks 2, 8 and 12 in MSDBP [ Time Frame: Baseline and Weeks 2, 8 and 12 ]
5. Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12 [ Time Frame: Weeks 2, 4, 8 and 12 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Male and female outpatients
• 18 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

Exclusion Criteria:

• 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)

Contacts and Locations

Locations

United States, Louisiana

Egan Healthcare

Metairie, Louisiana, United States, 70002

Sponsors and Collaborators

Novartis

Investigators

• Principal Investigator: Suzanne Oparil, MD et al; University of Alabama at Birmingham

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Novartis, pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00666536 History of Changes
• Other Study ID Numbers: CVAA489AUS02
• First Posted: April 25, 2008
• Results First Posted: December 10, 2010
• Last Update Posted: October 27, 2016
• Last Verified: April 2011

Keywords provided by Novartis:

Hypertension; adults; Valsartan + Amlodipine; Angiotensin Receptor Blockers

Additional relevant MeSH terms:

Amlodipine; Valsartan; Amlodipine, Valsartan Drug Combination; Hypertension; Vascular Diseases; Cardiovascular Diseases; Angiotensin Receptor Antagonists; Antihypertensive Agents; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vasodilator Agents; Angiotensin II Type 1 Receptor Blockers