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Completed

NCT Number: NCT01615198

Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension

The purpose of this study is to access the efficacy and safety of LCZ696 compared to olmesartan in elderly Asian patients for the treatment of hypertension.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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 must give written informed consent before any assessment is performed
  • Patients with essential hypertension, untreated or currently taking antihypertensive therapy must have a mean sitting systolic blood pressure ≥ 150 mmHg and < 180 mmHg
  • Patients must be able to communicate and comply with all study requirements and demonstrate good medication compliance

Exclusion criteria

  • Patients with severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥180 mmHg). Patients with history of angioedema, drug-related or otherwise
  • Patients with history or evidence of a secondary form of hypertension
  • Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke
  • History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
  • Current angina pectoris requiring medication (other than patients on a stable dose of oral or topical nitrates).
  • Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled and are not on a stable dose of antidiabetic medication
  • Patients with previous or current diagnosis of heart failure (NYHA Class II-IV).
  • Patients with a clinically significant valvular heart disease at the time of screening
  • Women of child-bearing potential, who do not use adequate birth control methods Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Olmesartan

Drug

10 mg, 20 mg, 40 mg capsules

Placebo

Drug

Matching placebo of LCZ696 tablet, matching placebo of Olmesartan capsule

LCZ696

Drug

100 mg, 200 mg tablets

Primary outcomes

  1. Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

    Time frame: Baseline, 10 weeks

    Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.

Secondary outcomes

  1. Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)

    Time frame: Baseline, 10 weeks

    ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. 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)

    Time frame: Baseline, 4 weeks, 14 weeks

    Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicated improvement.

  3. Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)

    Time frame: Baseline, 10 weeks

    ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.

  4. Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

    Time frame: Baseline, 10 weeks

    Sitting BP measurements was performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.

  5. Change From Baseline in Mean Sitting Pulse Pressure

    Time frame: Baseline, 4 weeks, 10 weeks, 14 weeks

    Pulse rate was with automated BP device after the 4th blood pressure measurement at each visit.

  6. Change From Baseline in Daytime and Nighttime maSBP/maDBP

    Time frame: Baseline, 10 weeks

    ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.

  7. Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers

    Time frame: Baseline, 10 weeks

    ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement.

  8. Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers

    Time frame: Baseline, 10 weeks

    ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement.

  9. Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)

    Time frame: 4 weeks, 10 weeks, 14 weeks

    A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg.

  10. Number of Participants Achieving Successful Response in msSBP and msDBP

    Time frame: 4 weeks,10 weeks, 14 weeks

    Blood pressure response in msSBP was defined as a mean sitting BP < 140 mmHg or a >=20 mmHg reduction from baseline. Blood pressure response in msDBP was defined as a mean sitting diastolic blood pressure, 90 mmHg or >=10 mmHg reduction from baseline.

  11. Number of Participants With Adverse Events, Serious Adverse Events and Death

    Time frame: 14 weeks

    Adverse event monitoring was conducted throughout the study.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A 14 Week, Randomized, Double-blind, Multi-center, Parallel Group, Active Controlled Study to Evaluate the Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Elderly Patients With Essential Hypertension

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 8, 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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