Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension
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ClinicalTrials.gov Identifier: NCT00765947 |
Recruitment Status
:
Completed
First Posted
: October 3, 2008
Results First Posted
: January 11, 2011
Last Update Posted
: March 11, 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 | October 2, 2008 | ||
First Posted Date ICMJE | October 3, 2008 | ||
Results First Submitted Date | December 13, 2010 | ||
Results First Posted Date | January 11, 2011 | ||
Last Update Posted Date | March 11, 2011 | ||
Study Start Date ICMJE | September 2008 | ||
Actual Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen [ Time Frame: 24 weeks ] For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure [msSBP] < 130 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 80 mmHg.
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Original Primary Outcome Measures ICMJE |
Percentage of patients reaching BP target [ Time Frame: 24 weeks ] | ||
Change History | Complete list of historical versions of study NCT00765947 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 | Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension | ||
Official Title ICMJE | A Twenty-four Week, Open-label, Non-comparative, Multi-center Study to Assess the Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension. | ||
Brief Summary | This study will assess the efficacy of an aliskiren based treatment regimen in reaching blood pressure (BP) target in patients with mild to moderate hypertension. (defined as mean sitting Systolic Blood Pressure [msSBP] ≥ 140 mmHg and < 180 mmHg and/or mean sitting Diastolic Blood Pressure [msDBP] ≥ 90 and <110 mmHg). | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 4 | ||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Essential Hypertension ( Mild to Moderate) | ||
Intervention ICMJE |
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Study Arms | Experimental: Aliskiren-based regimen
All pts starting on aliskiren 150 mg (uptitrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (uptitrated to 25 mg) and amlodipine 5 mg (uptitrated to 10 mg), as necessary to achieve the Blood Pressure goal.
Interventions:
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Publications * | Not Provided | ||
* 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 |
256 | ||
Original Estimated Enrollment ICMJE |
230 | ||
Study Completion Date | August 2009 | ||
Actual Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply. |
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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 | France, Hungary, Romania, Slovakia | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00765947 | ||
Other Study ID Numbers ICMJE | CSPP100A2360 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | External Affairs, Novartis | ||
Study Sponsor ICMJE | Novartis | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Novartis | ||
Verification Date | March 2011 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |