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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01593787
First received: April 30, 2012
Last updated: August 7, 2015
Last verified: August 2015

April 30, 2012
August 7, 2015
May 2012
March 2013   (final data collection date for primary outcome measure)
Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Percentage of patients with total adverse events, serious adverse events and death were reported.
Number of participants with reported adverse events ( total adverse events, serious adverse events and death) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Summerized report on adverse events such as number of patients with total adeverse events, serious adverse events and death will be reported.
Complete list of historical versions of study NCT01593787 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8 [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving a Successful BP Control at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    SBP control was defined as msSBP <130 mmHg.
  • Percentage of Participants Achieving DBP Control at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Successful response rate was defined as msDBP <80 mmHg or a reduction of ≥10 mmHg from baseline.
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Successful response rate is defined as msDBP <80 mmHg or a reduction of ≥10 mmHg from baseline.
Not Provided
Not Provided
 
Safety and Tolerability and Efficacy of LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction
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

This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients with renal dysfunction.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension With Renal Dysfunction
Drug: LCZ696
100 mg, 200 mg, 400 mg tablets.
  • 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
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.
 
Completed
32
March 2013
March 2013   (final data collection date for primary outcome measure)

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.

Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01593787
CLCZ696A1304
Yes
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP