The Effects of Moderate vs. Aggressive Treatment With Valsartan + Amlodipine on Patients With Hypertension Uncontrolled by Angiotensin-Receptor Blocker (Herein, ARB) Monotherapy (EXTRA)
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ClinicalTrials.gov Identifier: NCT00666536 |
Recruitment Status :
Completed
First Posted : April 25, 2008
Results First Posted : December 10, 2010
Last Update Posted : October 27, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: valsartan and amlodipine | Phase 4 |
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 |

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)
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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)
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Drug: valsartan and amlodipine |
- Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP) [ Time Frame: Baseline and Week 4 ]
- 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 ]
- Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: Baseline and Week 4 ]
- Change From Baseline to Weeks 2, 8 and 12 in MSSBP [ Time Frame: Baseline and Weeks 2, 8 and 12 ]
- Change From Baseline to Weeks 2, 8 and 12 in MSDBP [ Time Frame: Baseline and Weeks 2, 8 and 12 ]
- Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12 [ Time Frame: Weeks 2, 4, 8 and 12 ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00666536
United States, Louisiana | |
Egan Healthcare | |
Metairie, Louisiana, United States, 70002 |
Principal Investigator: | Suzanne Oparil, MD et al | University of Alabama at Birmingham |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novartis, pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00666536 History of Changes |
Other Study ID Numbers: |
CVAA489AUS02 |
First Posted: | April 25, 2008 Key Record Dates |
Results First Posted: | December 10, 2010 |
Last Update Posted: | October 27, 2016 |
Last Verified: | April 2011 |
Hypertension adults Valsartan + Amlodipine Angiotensin Receptor Blockers |
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 |