Safety and Tolerability and Efficacy of LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction
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ClinicalTrials.gov Identifier: NCT01593787 |
Recruitment Status
:
Completed
First Posted
: May 8, 2012
Results First Posted
: August 13, 2015
Last Update Posted
: August 13, 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 | April 30, 2012 | |||
First Posted Date ICMJE | May 8, 2012 | |||
Results First Submitted Date | July 8, 2015 | |||
Results First Posted Date | August 13, 2015 | |||
Last Update Posted Date | August 13, 2015 | |||
Study Start Date ICMJE | May 2012 | |||
Actual Primary Completion Date | March 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death) [ Time Frame: 8 weeks ] Percentage of patients with total adverse events, serious adverse events and death were reported.
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Original Primary Outcome Measures ICMJE |
Number of participants with reported adverse events ( total adverse events, serious adverse events and death) [ Time Frame: 8 weeks ] Summerized report on adverse events such as number of patients with total adeverse events, serious adverse events and death will be reported.
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Change History | Complete list of historical versions of study NCT01593787 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 | Safety and Tolerability and Efficacy of LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction | |||
Official Title ICMJE | A Multi-center, Open Label Study for Evaluation of the Safety, Tolerability and Efficacy of 8-week Treatment With LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction | |||
Brief Summary | This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients with renal dysfunction. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Hypertension With Renal Dysfunction | |||
Intervention ICMJE | Drug: LCZ696
100 mg, 200 mg, 400 mg tablets. |
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Study Arms |
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Publications * | Ito S, Satoh M, Tamaki Y, Gotou H, Charney A, Okino N, Akahori M, Zhang J. Safety and efficacy of LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor, in Japanese patients with hypertension and renal dysfunction. Hypertens Res. 2015 Apr;38(4):269-75. doi: 10.1038/hr.2015.1. Epub 2015 Feb 19. | |||
* 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 |
32 | |||
Original Estimated Enrollment ICMJE |
28 | |||
Actual Study Completion Date | March 2013 | |||
Actual Primary Completion Date | March 2013 (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 | 20 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 | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01593787 | |||
Other Study ID Numbers ICMJE | CLCZ696A1304 | |||
Has Data Monitoring Committee | Yes | |||
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 |