Efficacy and Safety of LCZ696A in Patients With Essential Hypertension
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ClinicalTrials.gov Identifier: NCT00549770 |
Recruitment Status
:
Completed
First Posted
: October 26, 2007
Results First Posted
: August 10, 2015
Last Update Posted
: August 25, 2015
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Tracking Information | |||||||
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First Submitted Date ICMJE | October 5, 2007 | ||||||
First Posted Date ICMJE | October 26, 2007 | ||||||
Results First Submitted Date | August 10, 2012 | ||||||
Results First Posted Date | August 10, 2015 | ||||||
Last Update Posted Date | August 25, 2015 | ||||||
Study Start Date ICMJE | September 2007 | ||||||
Actual Primary Completion Date | July 2008 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: baseline, week 8 ] Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.
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Original Primary Outcome Measures ICMJE |
Mean sitting diastolic blood pressure lowering from baseline to week 8 of LCZ696 compared to valsartan | ||||||
Change History | Complete list of historical versions of study NCT00549770 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
MSSBP/MSDBP lowering from baseline to week 8 of LCZ696 compared to placebo | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Efficacy and Safety of LCZ696A in Patients With Essential Hypertension | ||||||
Official Title ICMJE | A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group, Dose Range Study to Evaluate the Efficacy and Safety of LCZ696 Comparatively to Valsartan, and to Evaluate AHU377 to Placebo After 8 Week Treatment in Patients With Essential Hypertension | ||||||
Brief Summary | This study was a dose-ranging efficiacy study in patients with essential hypertension to assess the blood pressure lowering effect, and safety of LCZ696 compared to valsartan and placebo. The study will also evaluate the efficacy and safety of AHU377 as compared to placebo. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 2 | ||||||
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 |
1334 | ||||||
Original Estimated Enrollment ICMJE |
1320 | ||||||
Actual Study Completion Date | July 2008 | ||||||
Actual Primary Completion Date | July 2008 (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 to 75 Years (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Argentina, Canada, Denmark, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, Netherlands, Poland, Russian Federation, Slovakia, Spain, Sweden, Taiwan, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00549770 | ||||||
Other Study ID Numbers ICMJE | CLCZ696A2201 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Novartis ( Novartis Pharmaceuticals ) | ||||||
Study Sponsor ICMJE | Novartis Pharmaceuticals | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Novartis | ||||||
Verification Date | August 2015 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |