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

Last updated: October 2, 2015
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Williams Syndrome

High Blood Pressure (Hypertension - Pediatric)

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT01646671
CLCZ696A1305
  • Ages > 20
  • All Genders

Study Summary

This study assessed the safety, tolerability, and efficacy of LCZ696 in severe hypertensive Japanese patients

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 currentantihypertensive 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 enrolledinto the active drug treatment epoch. Other protocol defined inclusion/exclusion criteria may apply.

Study Design

Total Participants: 35
Study Start date:
July 01, 2012
Estimated Completion Date:
February 28, 2013

Study Description

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.

Connect with a study center

  • Novartis Investigative Site

    Yokohama, Kanagawa 231-0023
    Japan

    Site Not Available

  • Novartis Investigative Site

    Yokohama-city, Kanagawa 231-0023
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kyoto-city, Kyoto 606-8507
    Japan

    Site Not Available

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo 113-0031
    Japan

    Site Not Available

  • Novartis Investigative Site

    Hachioji-city, Tokyo 192-0918
    Japan

    Site Not Available

  • Novartis Investigative Site

    Minato-ku, Tokyo 108-0075
    Japan

    Site Not Available

  • Novartis Investigative Site

    Ota-ku, Tokyo 143-0023
    Japan

    Site Not Available

  • Novartis Investigative Site

    Shibuya-ku, Tokyo 150-0002
    Japan

    Site Not Available

  • Novartis Investigative Site

    Shinagawa-ku, Tokyo 141-0032
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kyoto, 606-8507
    Japan

    Site Not Available

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