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Completed

NCT Number: NCT00549770

Efficacy and Safety of LCZ696A in Patients With Essential Hypertension

This study was a dose-ranging efficiacy study in patients with essential hypertension to assess the blood pressure lowering effect, and safety of LCZ696 compared to valsartan and placebo. The study will also evaluate the efficacy and safety of AHU377 as compared to placebo.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Caba, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or females from 18 up to and including 75 years
  • Patients with mild-to-moderate uncomplicated essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy of 2 drugs; therapy with a fixed dose combination of two active substances represents 2 drugs)
  • Untreated patients must have had an office msDBP≥ 95 mmHg at the randomization visit (Visit 3) and the 2 preceding visits (Visits 1 and 2).
  • Treated patients must have had an office msDBP≥ 90 mmHG after washout (Visit 2), and a msDBP> 95 mmHg at baseline (Visit 3);

Exclusion criteria

  • Severe hypertension (msSBP ≥180 mmHg and/or msDBP ≥110 mmHg)
  • History of angioedema, drug-related or otherwise, as reported by the patient
  • Type 1 or Type 2 diabetes mellitus (according to the ADA criteria)
  • History or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease, etc.
  • History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral intervention), stroke, TIA (transient ischemic attack), carotid artery stenosis, aortic aneurysm or peripheral arterial disease

Treatment and study plan

LCZ696

Drug

valsartan

Drug

AHU377

Drug

Placebo

Drug

Primary outcomes

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

    Time frame: baseline, week 8

    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, week 8

    Sitting BP measurements were performed at screening through the end of the study at every study visit.

  2. Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP

    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.

  3. Change From Baseline in Daytime maDBP and maSBP

    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 avergae 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.

  4. Change From Baseline in Nighttime maDBP and maSBP

    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.

  5. Percentage 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.

  6. Percentage 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.

  7. Percentage of Participants Who Achieved Successful Control in msDBP

    Time frame: 8 weeks

    Successful control in msDBP is defined as msDBP <90 mmHg.

  8. Percentage of Participants Who Achieved Successful Control in msSBP

    Time frame: 8 weeks

    Successful control in msSBP is defined as <140 mmHg.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group, Dose Range Study to Evaluate the Efficacy and Safety of LCZ696 Comparatively to Valsartan, and to Evaluate AHU377 to Placebo After 8 Week Treatment in Patients With Essential Hypertension

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 26, 2007
Registry last updated
Aug 25, 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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