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Completed

NCT Number: NCT01646671

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

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

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Key information

Conditions

Severe Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Yokohama, Kanagawa, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LCZ696

Drug

LCZ696 200 mg tablet once daily

Primary outcomes

  1. Percentage of Participants With Adverse Events (AEs), Serious Adverse Events and Deaths

    Time frame: Week 8

    Adverse events, serious adverse events deaths were monitored from screening to week 8.

Secondary outcomes

  1. Change From Baseline in msSBP and msDBP at Week 8

    Time frame: Baseline, 8 weeks

    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.

  2. Percentage of Participants With Successful Blood Pressure (BP) Control in msSBP/msDBP at End of Study

    Time frame: 8 weeks

    Successful BP control in patients with severe hypertension at the end of study treatment was defined as follows: msSBP/msDBP< 140/90 mmHg.

  3. Percentage of Participants Achieving Successful msSBP Control at End of Study

    Time frame: 8 weeks

    Successful msSBP control in patients with severe hypertension at the end of study treatment was defined as msSBP <140 mmHg.

  4. Percentage of Participants Achieving Successful msDBP Control at End of Study

    Time frame: 8 weeks

    Successful msDBP control in patients with severe hypertension at the end of study treatment was defined as msDBP < 90 mmHg.

  5. Percentage of Participants With SBP Response at End of Study

    Time frame: Baseline, 8 weeks

    SBP response was defined as <140 mmHg or a reduction ≥ 20 mmHg from baseline.

  6. Percentage of Participants With DBP Response at End of Study

    Time frame: Baseline, 8 weeks

    DBP response was defined as <90 mmHg or a reduction ≥ 10 mmHg from baseline.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 20, 2012
Registry last updated
Oct 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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