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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 18, 2012

Last Updated Date

February 28, 2013

Start Date ^ICMJE

July 2012

Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01646671 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

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 Severe Hypertensive Patients

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 Patients With Severe Hypertension

Brief Summary

This study will assess the safety, tolerability, and efficacy of LCZ696 in severe hypertensive patients

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Severe Hypertension

Intervention ^ICMJE

Drug: LCZ696

LCZ696 200mg tablet once daily

Study Arm (s)

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

Publications *

Not Provided

* 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

Enrollment ^ICMJE

Completion Date

February 2013

Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01646671

Other Study ID Numbers ^ICMJE

CLCZ696A1305

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

February 2013

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

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