Aliskiren/Amlodipine/Hydrochlorothiazide (HCTZ) Versus Aliskiren/Amlodipine in US Minority Patients With Stage II Systolic Hypertension (ASCENT)
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ClinicalTrials.gov Identifier: NCT00942994 |
Recruitment Status
:
Completed
First Posted
: July 21, 2009
Results First Posted
: April 27, 2011
Last Update Posted
: June 8, 2011
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Sponsor:
Novartis
Information provided by:
Novartis
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Tracking Information | ||||
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First Submitted Date ICMJE | July 19, 2009 | |||
First Posted Date ICMJE | July 21, 2009 | |||
Results First Submitted Date | March 29, 2011 | |||
Results First Posted Date | April 27, 2011 | |||
Last Update Posted Date | June 8, 2011 | |||
Study Start Date ICMJE | June 2009 | |||
Actual Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 [ Time Frame: Baseline and week 8 ] To evaluate change from baseline in MSSBP after 8 weeks of treatment with an aliskiren, amlodipine, and HCTZ treatment regimen versus an aliskiren and amlodipine treatment regimen in minority patients with Stage 2 hypertension.
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Original Primary Outcome Measures ICMJE |
Change from baseline in Mean Seated Systolic Blood Pressure (MSSBP) [ Time Frame: 8 weeks ] | |||
Change History | Complete list of historical versions of study NCT00942994 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Aliskiren/Amlodipine/Hydrochlorothiazide (HCTZ) Versus Aliskiren/Amlodipine in US Minority Patients With Stage II Systolic Hypertension | |||
Official Title ICMJE | An 8-week Multicenter, Randomized, Double-blind, Active Controlled, Parallel Group, Forced Titration Study to Evaluate the Efficacy and Safety of Aliskiren/Amlodipine/HCTZ Compared to Aliskiren/Amlodipine in US Minority Patients With Stage 2 Hypertension | |||
Brief Summary | The purpose of the study is to compare the combination of aliskiren, amlodipine and Hydrochlorothiazide (HCTZ) versus the combination of aliskiren and amlodipine as therapy in minority Stage 2 hypertensive patients. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Hypertension | |||
Intervention ICMJE |
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Study Arms |
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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 |
412 | |||
Original Estimated Enrollment ICMJE |
402 | |||
Study Completion Date | Not Provided | |||
Actual Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | 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 | NCT00942994 | |||
Other Study ID Numbers ICMJE | CSPA100AUS02 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | External Affairs, Novartis Pharmaceuticals | |||
Study Sponsor ICMJE | Novartis | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Novartis | |||
Verification Date | May 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |