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Completed

NCT Number: NCT01193101

Efficacy and Safety of LCZ696 Compared to Placebo in Patients With Essential Hypertension

This study is a phase 2 study in patients with essential hypertension.

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Key information

Conditions

Hypertension Cardiovascular Diseases Essential Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Shijiazhuang, Hebei, China

Loading trial locations.

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 mild to moderate essential hypertension, untreated or currently taking antihypertensive therapy (mean sitting diastolic blood pressure ≥ 95 mmHg and < 110 mmHg, and mean sitting systolic blood pressure ≥ 140 mmHg and < 180 mmHg).
  • Patients must be willing and able to undergo ambulatory blood pressure monitoring for a 24-hr period at the beginning and the end of the 8-week treatment.
  • Patient must be able to communicate and comply with all study requirements and demonstrate good medication compliance.

Exclusion criteria

  • Patients with severe hypertension.
  • Patients with history of angioedema, drug-related or otherwise
  • Pregnant or nursing women
  • Women of child-bearing potential , who do not use adequate birth control methods
  • History or evidence of a secondary form of hypertension.
  • History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind, stroke, TIA, carotid artery stenosis, aortic aneurysm, or peripheral arterial disease.
  • Diabetes mellitus.
  • Previous or current diagnosis of heart failure (NYHA Class II-IV).
  • Clinically significant valvular heart disease at the time of screening.

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

LCZ696

Drug

LCZ696

Placebo

Drug

matching placebo to LCZ696

Primary outcomes

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

    Time frame: Baseline, 8 weeks

    Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.

Secondary outcomes

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

    Time frame: Baseline, 8 weeks

    Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.

  2. Change From Baseline in 24 Hour Mean Ambulatory DBP and SBP

    Time frame: Baseline, 8 weeks

    Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. A negative change from baseline indicates improvement.

  3. Change From Baseline in Daytime Mean Ambulatory DBP and SBP

    Time frame: Baseline, 8 weeks

    Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Daytime mean SBP and DBP were the averages of the hourly means between 6 am and 10 pm. A negative change from baseline indicates improvement.

  4. Change From Baseline in Nighttime Mean Ambulatory DBP and SBP

    Time frame: Baseline, 8 weeks

    Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Nighttime mean SBP and DBP were the averages of the hourly means between 10 pm and 6 am. A negative change from baseline indicates improvement.

  5. Change From Baseline in Mean Sitting Pulse Pressure

    Time frame: Baseline, 8 weeks

    Mean sitting pulse pressure is the difference in msSBP and msDBP (msSBP - msDBP). A negative change from baseline indicates improvement.

  6. Change From Baseline in Mean Ambulatory Pulse Pressure

    Time frame: Baseline, 8 weeks

    Mean ambulatory pulse pressure is the difference in maSBP and maDBP (maSBP - maDBP). A negative change from baseline indicates improvement.

  7. Number of Participants Who Achieved a Successful Response in msDBP

    Time frame: 8 weeks

    Successful response in msDBP is defined as msDBP <90 mmHg or a reduction ≥ 10 mmHg from baseline.

  8. Number of Participants Who Achieved a Successful Response in msSBP

    Time frame: 8 weeks

    Successful response in msSBP is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.

  9. Number of Participants Who Achieved Successful BP Control

    Time frame: 8 weeks

    BP control is defined as BP < 140/90 mmHg.

  10. Trough to Post-dosing Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP

    Time frame: baseline, 8 weeks

    Trough to post-dosing hour ratio at each post-dosing hour = [trough LSM of LCZ696 - trough LSM of placebo]/[post-dosing hour LSM of LCZ696 - post-dosing hour LSM of placebo]

  11. Trough to Post-dosing Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP

    Time frame: baseline, 8 weeks

    Trough to post-dosing hour ratio at each post-dosing hour = [trough LSM of LCZ696 - trough LSM of placebo]/[post-dosing hour LSM of LCZ696 - post-dosing hour LSM of placebo]

  12. Change From Week 8 to Week 9 in msDBP and msSBP After Single-blind Placebo Withdrawal at Week 8

    Time frame: 8 weeks, 9 weeks

    From week 8 to week 9, participants entered a single-blind placebo withdrawal period to assess the effect of LCZ696 on blood pressure following its discontinuation. Participants, who were randomized to the LCZ696 treatment groups, were discontinued from CLCZ696 at the end of week 8 and all 4 treatment groups received single-blind placebo for 1 week post week 8. A positive change from week 8 to week 9 indicates worsening.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Placebo After 8 Weeks Treatment in Patients With Essential Hypertension

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 1, 2010
Registry last updated
Feb 15, 2016

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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