Safety and Tolerability and Efficacy of LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction

Tracking Information
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; (submitted: August 7, 2015)	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.
Original Primary Outcome Measures ICMJE; (submitted: May 7, 2012)	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.
Change History	Complete list of historical versions of study NCT01593787 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: August 7, 2015)	Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8 [ Time Frame: baseline, 8 weeks ]Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements.; Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8 [ Time Frame: baseline, 8 weeks ]; Percentage of Participants Achieving a Successful BP Control at Week 8 [ Time Frame: 8 weeks ]A successful BP control was defined as msSBP <130 mmHg and msDBP <80 mmHg; Percentage of Participants Achieving SBP Control at Week 8 [ Time Frame: 8 weeks ]SBP control was defined as msSBP <130 mmHg.; Percentage of Participants Achieving DBP Control at Week 8 [ Time Frame: 8 weeks ]DBP control was defined as msDBP <80 mmHg.; Percentage of Participants Achieving a Successful Response Rate in msSBP at Week 8 [ Time Frame: 8 weeks ]Successful response rate was defined as msSBP <130 mmHg or a reduction of ≥20 mmHg from baseline; Percentage of Participants Achieving a Successful Response Rate in msDBP at Week 8 [ Time Frame: 8 weeks ]Successful response rate was defined as msDBP <80 mmHg or a reduction of ≥10 mmHg from baseline.
Original Secondary Outcome Measures ICMJE; (submitted: May 7, 2012)	Change from baseline in mean sitting systolic blood pressure (msSBP) and mean sitting Diastolic Blood Pressure (msDBP) at week 8 [ Time Frame: baseline, 8 weeks ]Sitting BP measurements will be performed at screening through the end of study at every visit. Four separate sitting BP will be obtained with a full two-minute interval between measurements.; Percentage of patients achieving a successful BP control at week 8 [ Time Frame: 8 weeks ]A successful BP control is defined as msSBP <130 mmHg and msDBP <80 mmHg; Percentage of patients achieving a successful response rate in msSBP at week 8 [ Time Frame: 8 weeks ]Successful response rate is defined as msSBP <130 mmHg or a reduction of ≥20 mmHg from baseline; Percentage of patients achieving a successful response rate in msDBP at week 8 [ Time Frame: 8 weeks ]Successful response rate is defined as msDBP <80 mmHg or a reduction of ≥10 mmHg from baseline.
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
Condition ICMJE	Hypertension With Renal Dysfunction
Intervention ICMJE	Drug: LCZ696; 100 mg, 200 mg, 400 mg tablets.
Study Arms	Experimental: LCZ696 100 mg All participants were started on LCZ696 100 mg once daily on day 1. Intervention: Drug: LCZ696; Experimental: LCZ696 200 mg All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg. Intervention: Drug: LCZ696; Experimental: LCZ696 400 mg All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg. Intervention: Drug: LCZ696
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: August 7, 2015)	32
Original Estimated Enrollment ICMJE; (submitted: May 7, 2012)	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: Renal findings: Hypertensive patients with renal dysfunction and stable renal condition at least 4 weeks before screening visit.; Satisfy office msSBP ≥140 mmHg and <180 mmHg at baseline. Exclusion Criteria: Patients show msDBP ≥110 mmHg and/or msSBP ≥180 mmHg.; History of angioedema, drug-related or otherwise, as reported by the patient.; Any other following renal disorder:; Patients show eGFR < 15mL/min/1.73m^2; Patients on dialysis; Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch. Other protocol-defined inclusion/exclusion criteria may apply.
Sex/Gender	Sexes Eligible for Study: All
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	Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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