Efficacy and Safety of LCZ696A in Patients With Essential Hypertension

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00549770
First received: October 5, 2007
Last updated: August 30, 2010
Last verified: August 2010

October 5, 2007
August 30, 2010
September 2007
July 2008   (final data collection date for primary outcome measure)
Mean sitting diastolic blood pressure change of LCZ696 compared to valsartan [ Time Frame: from baseline to week 8 ] [ Designated as safety issue: No ]
Mean sitting diastolic blood pressure lowering from baseline to week 8 of LCZ696 compared to valsartan
Complete list of historical versions of study NCT00549770 on ClinicalTrials.gov Archive Site
MSSBP/MSDBP change of LCZ696 compared to placebo [ Time Frame: baseline to week 8 ] [ Designated as safety issue: No ]
MSSBP/MSDBP lowering from baseline to week 8 of LCZ696 compared to placebo
Not Provided
Not Provided
 
Efficacy and Safety of LCZ696A in Patients With Essential Hypertension
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

This study is a proof of efficacy dose ranging 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: LCZ696
  • Drug: Valsartan
  • Drug: AHU377
  • Drug: Placebo
  • Experimental: LCZ696 (Dose 1)
    Intervention: Drug: LCZ696
  • Experimental: LCZ696 (Dose 2)
    Intervention: Drug: LCZ696
  • Experimental: LCZ696 (Dose 3)
    Intervention: Drug: LCZ696
  • Active Comparator: Valsartan (Dose 1)
    Intervention: Drug: Valsartan
  • Active Comparator: Valsartan (Dose 2)
    Intervention: Drug: Valsartan
  • Active Comparator: Valsartan (Dose 3)
    Intervention: Drug: Valsartan
  • Experimental: AHU377
    Intervention: Drug: AHU377
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Ruilope LM, Dukat A, Böhm M, Lacourcière Y, Gong J, Lefkowitz MP. Blood-pressure reduction with LCZ696, a novel dual-acting inhibitor of the angiotensin II receptor and neprilysin: a randomised, double-blind, placebo-controlled, active comparator study. Lancet. 2010 Apr 10;375(9722):1255-66. doi: 10.1016/S0140-6736(09)61966-8. Epub 2010 Mar 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1334
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Willing to sign informed consent
  • Male and females from 18 up to 75 years inclusive Mild-to-moderate uncomplicated essential hypertension Medication compliance ≥80 % compliance rate during the run-in period

Exclusion Criteria:

  • Severe hypertension (MSSBP ≥180 mmHg and/or MSDBP ≥110 mmHg)
  • Women of child-bearing potential (WOCBP) unless they are post-menopausal or use predefined acceptable methods of contraception
  • 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 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 Other protocol-defined inclusion/exclusion criteria may apply
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT00549770
CLCZ696A2201
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP