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NCT Number: NCT01593787

Safety and Tolerability and Efficacy of LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction

This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients with renal dysfunction.

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Key information

Conditions

Hypertension With Renal Dysfunction Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Sapporo, Hokkaido, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Renal findings: Hypertensive patients with renal dysfunction and stable renal condition at least 4 weeks before screening visit.
  • Satisfy office msSBP ≥140 mmHg and <180 mmHg at baseline.

Exclusion criteria

  • Patients show msDBP ≥110 mmHg and/or msSBP ≥180 mmHg.
  • History of angioedema, drug-related or otherwise, as reported by the patient.
  • Any other following renal disorder:
  • Patients show eGFR < 15mL/min/1.73m^2
  • Patients on dialysis
  • 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

100 mg, 200 mg, 400 mg tablets.

Primary outcomes

  1. Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death)

    Time frame: 8 weeks

    Percentage of patients with total adverse events, serious adverse events and death were reported.

Secondary outcomes

  1. Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) 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 were obtained with a full two-minute interval between measurements.

  2. Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8

    Time frame: baseline, 8 weeks

  3. Percentage of Participants Achieving a Successful BP Control at Week 8

    Time frame: 8 weeks

    A successful BP control was defined as msSBP <130 mmHg and msDBP <80 mmHg

  4. Percentage of Participants Achieving SBP Control at Week 8

    Time frame: 8 weeks

    SBP control was defined as msSBP <130 mmHg.

  5. Percentage of Participants Achieving DBP Control at Week 8

    Time frame: 8 weeks

    DBP control was defined as msDBP <80 mmHg.

  6. Percentage of Participants Achieving a Successful Response Rate in msSBP at Week 8

    Time frame: 8 weeks

    Successful response rate was defined as msSBP <130 mmHg or a reduction of ≥20 mmHg from baseline

  7. Percentage of Participants Achieving a Successful Response Rate in msDBP at Week 8

    Time frame: 8 weeks

    Successful response rate was defined as msDBP <80 mmHg or a reduction of ≥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 Hypertensive Patients With Renal Dysfunction

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 8, 2012
Registry last updated
Aug 13, 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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