Trial record 24 of 100 for:
AMLODIPINE AND VALSARTAN
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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Sponsor:
Novartis
Information provided by:
Novartis
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Tracking Information | ||||
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First Submitted Date ICMJE | April 23, 2008 | |||
First Posted Date ICMJE | April 25, 2008 | |||
Results First Submitted Date ICMJE | November 16, 2010 | |||
Results First Posted Date ICMJE | December 10, 2010 | |||
Last Update Posted Date | October 27, 2016 | |||
Study Start Date ICMJE | March 2008 | |||
Actual Primary Completion Date | January 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP) [ Time Frame: Baseline and Week 4 ] | |||
Original Primary Outcome Measures ICMJE |
Change in Mean Sitting Systolic Blood Pressure (herein, MSSBP) after 4 weeks [ Time Frame: 4 weeks ] | |||
Change History | Complete list of historical versions of study NCT00666536 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Proportion of patients achieving blood pressure goal (<140/90 mmHg), at 2, 4, 8 and 12 weeks [ Time Frame: 12 weeks ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | The Effects of Moderate vs. Aggressive Treatment With Valsartan + Amlodipine on Patients With Hypertension Uncontrolled by Angiotensin-Receptor Blocker (Herein, ARB) Monotherapy | |||
Official Title ICMJE | 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 | |||
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 | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Hypertension | |||
Intervention ICMJE | Drug: valsartan and amlodipine | |||
Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
728 | |||
Original Estimated Enrollment ICMJE |
678 | |||
Study Completion Date ICMJE | Not Provided | |||
Actual Primary Completion Date | January 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00666536 | |||
Other Study ID Numbers ICMJE | CVAA489AUS02 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Novartis, pharmaceuticals | |||
Study Sponsor ICMJE | Novartis | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Novartis | |||
Verification Date | April 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |