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: February 28, 2013
Last verified: February 2013

July 18, 2012
February 28, 2013
July 2012
February 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01646671 on ClinicalTrials.gov Archive Site
  • 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
Same as current
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 will assess the safety, tolerability, and efficacy of LCZ696 in severe hypertensive patients

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Severe Hypertension
Drug: LCZ696
LCZ696 200mg tablet once daily
Experimental: LCZ696
Patients will be started from LCZ696 200 mg (once daily), and will be titrated over LCZ696 400 mg (once daily) based on patients' blood pressure and integrated condition.Another class of antihypertensive drug (other than ARB, ACEi, or fixed combination containing ARB or ACEi) can be added or dose of concomitant antihypertensive drug can be increased if patients are already on LCZ696 400mg and blood pressure is not controlled according to protocol description. Patients, who are already on LCZ696 400 mg dose, should not change the LCZ696 dose.
Intervention: Drug: LCZ696
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
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 mH
  • 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
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01646671
CLCZ696A1305
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2013

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