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Safety and Tolerability and Efficacy of LCZ696 in Japanese Severe Hypertensive Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01646671
First received: July 18, 2012
Last updated: October 2, 2015
Last verified: October 2015

July 18, 2012
October 2, 2015
July 2012
February 2013   (final data collection date for primary outcome measure)
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events and Deaths [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
Adverse events, serious adverse events deaths were monitored from screening to week 8.
Number of patients with adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Summarize the overall report of adverse event, serious adverse events including death, discontinuation due to adverse events, and notable laboratory abnormalities.
Complete list of historical versions of study NCT01646671 on ClinicalTrials.gov Archive Site
  • Change From Baseline in msSBP and msDBP 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 measurements were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline value.
  • Percentage of Participants With Successful Blood Pressure (BP) Control in msSBP/msDBP at End of Study [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Successful BP control in patients with severe hypertension at the end of study treatment was defined as follows: msSBP/msDBP< 140/90 mmHg.
  • Percentage of Participants Achieving Successful msSBP Control at End of Study [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Successful msSBP control in patients with severe hypertension at the end of study treatment was defined as msSBP <140 mmHg.
  • Percentage of Participants Achieving Successful msDBP Control at End of Study [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Successful msDBP control in patients with severe hypertension at the end of study treatment was defined as msDBP < 90 mmHg.
  • Percentage of Participants With SBP Response at End of Study [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    SBP response was defined as <140 mmHg or a reduction ≥ 20 mmHg from baseline.
  • Percentage of Participants With DBP Response at End of Study [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    DBP response was defined as <90 mmHg or a reduction ≥ 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 with successful blood pressure (BP) control rate in msSBP/msDBP at endpoint [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Successful control rate is defined as msSBP/msDBP< 140/90 mmHg at endpoint
  • Percentage of patients achieving a successful msSBP control at endpoint [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    A successful msSBP control is defined as msSBP <140 mmHg at endpoint
  • Percentage of patients achieving a successful msDBP control at endpoint [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    A successful BP control is defined as msDBP <90 mmHg at endpoint
  • Percentage of patients achieving a successful response rate in msSBP [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    Successful response rate in msSBP is defined as <140 mmHg or a reduction ≥ 20 mmHg from baseline
  • Percentage of patients achieving a successful response rate in msDBP [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    Successful response rate in msDBP is defined as <90 mmHg or a reduction ≥ 10 mmHg from baseline
Not Provided
Not Provided
 
Safety and Tolerability and Efficacy of LCZ696 in Japanese Severe Hypertensive Patients
A Multi-center, Open Label Study for Evaluation of the Safety, Tolerability and Efficacy of 8-week Treatment With LCZ696 in Japanese Patients With Severe Hypertension
This study assessed the safety, tolerability, and efficacy of LCZ696 in severe hypertensive Japanese patients

Summaries for treatment-emergent adverse events, serious adverse events and death were provided by the following actual treatment regimen (actual treatment patients received) in addition to all patients: LCZ696 200mg, 400mg, 400mg+other hypertensive medications.

Summaries for others than above were provided by the following treatment regimen (determined by the maximal treatment patients received) in addition to all patients: LCZ696 200mg, 400mg, 400mg+other hypertensive medications.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Severe Hypertension
  • Drug: LCZ696
    LCZ696 200 mg tablet once daily
  • Drug: LCZ696
    2 tablets of LCZ696 200 mg once daily titrated up from 1 tablet of 200 mg once daily
  • Drug: LCZ696
    2 tablets of LCZ696 200 mg once daily titrated up from 1 tablet of 200 mg once daily plus other HTN medications
  • Experimental: LCZ696 200 mg
    All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
    Intervention: Drug: LCZ696
  • Experimental: LCZ696 400 mg
    All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
    Intervention: Drug: LCZ696
  • Experimental: LCZ696 400 mg plus other hypertension (HTN) medications
    All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
    Intervention: Drug: LCZ696
Kario K, Tamaki Y, Okino N, Gotou H, Zhu M, Zhang J. LCZ696, a First-in-Class Angiotensin Receptor-Neprilysin Inhibitor: The First Clinical Experience in Patients With Severe Hypertension. J Clin Hypertens (Greenwich). 2016 Apr;18(4):308-14. doi: 10.1111/jch.12667.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Satisfy office msSBP ≥180 mmHg or office msDBP ≥110 mmHg at baseline

Exclusion Criteria:

  • Patients show msSBP ≥220 mmHg and/or msDBP ≥120 mmHg
  • History of angioedema, drug-related or otherwise, as reported by the patient
  • Patients unwilling or not able to discontinue safely the use of current antihypertensive medications during the study, as required by the protocol.
  • Patients have significant cardiovascular co-morbidities
  • 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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01646671
CLCZ696A1305
Yes
Not Provided
Not Provided
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
October 2015

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