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Efficacy and Safety of LCZ696A in Patients With Essential Hypertension

Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: LCZ696 (Drug); Valsartan (Drug); AHU377 (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis Pharmaceuticals

Summary

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.

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

Secondary outcome:

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

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

Change From Baseline in Daytime maDBP and maSBP

Change From Baseline in Nighttime maDBP and maSBP

Percentage of Participants Who Achieved a Successful Response in msDBP

Percentage of Participants Who Achieved a Successful Response in msSBP

Percentage of Participants Who Achieved Successful Control in msDBP

Percentage of Participants Who Achieved Successful Control in msSBP

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

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Additional Information

Starting date: September 2007
Last updated: July 11, 2015

Page last updated: August 20, 2015

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