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Completed

NCT Number: NCT01256411

A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension

The purpose of this study is to assess the long-term safety, tolerability and efficacy of LCZ696.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Chongqing, Chongqing Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who have successfully completed protocol No. CLCZ696A2219 and who, as judged by the study investigator, are able to continue in the current study.
  • Ability to communicate and comply with all study requirements and demonstrate good medication compliance during CLCZ696A2219.

Exclusion criteria

  • Patients who did not complete CLCZ696A2219.
  • Presence of significant protocol violation in CLCZ696A2219.
  • Patients who are deemed to be unable to comply with the protocol by the investigator.
  • Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

LCZ696

Drug

Participants received LCZ696 200 mg as the starting dose with optional down titration to 100 mg for tolerance and optional up titration to 400 mg for adequate blood pressure control.

Amlodipine

Drug

Optional add-on of amlodipine (5-10 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.

Hydrochlorothiazide (HCTZ)

Drug

Optional add-on of hydrochlorothiazide (HCTZ) (12.5-25 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.

Primary outcomes

  1. Number of Participants With Adverse Events, Serious Adverse Events, and Deaths (Analysis by Actual Treatment)

    Time frame: Baseline to 12 months

    Participants were monitored throughout the study for adverse events, serious adverse events and deaths.

Secondary outcomes

  1. Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Maximum Treatment)

    Time frame: Baseline, 12 months

    Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement.

  2. Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (Analysis by Mono or Combination Therapy)

    Time frame: Baseline, 12 months

    Sitting BP measurements were performed at every study visit. A negative change from baseline indicates improvement.

  3. Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Maximum Treatment)

    Time frame: Baseline to 12 months

    Blood pressure (BP) control is defined as BP <140/90 mmHg.

  4. Number of Participants With Blood Pressure Control Rate of <140/90 mmHg (Analysis by Mono or Combination Therapy)

    Time frame: Baseline to 12 months

    Blood pressure (BP) control is defined as BP <140/90 mmHg.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

An Open-label, Long-term Extension Study to Evaluate the Safety, Tolerability and Efficacy of 12 Months of LCZ696 Treatment in Patients With Essential Hypertension

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 8, 2010
Registry last updated
Oct 21, 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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