Efficacy and Safety of LCZ696A in Patients With Essential Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00549770
First received: October 5, 2007
Last updated: August 11, 2015
Last verified: August 2015

October 5, 2007
August 11, 2015
September 2007
July 2008   (final data collection date for primary outcome measure)
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement.
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
  • Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ]
    Sitting BP measurements were performed at screening through the end of the study at every study visit.
  • Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Daytime maDBP and maSBP [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Nighttime maDBP and maSBP [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Percentage of Participants Who Achieved a Successful Response in msDBP [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Successful response in msDBP is defined as msDBP <90 mmHg or a reduction ≥ 10 mmHg from baseline.
  • Percentage of Participants Who Achieved a Successful Response in msSBP [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Successful response in msSBP is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.
  • Percentage of Participants Who Achieved Successful Control in msDBP [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Successful control in msDBP is defined as msDBP <90 mmHg.
  • Percentage of Participants Who Achieved Successful Control in msSBP [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Successful control in msSBP is defined as <140 mmHg.
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 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.

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 100 mg
    Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
    Interventions:
    • Drug: LCZ696
    • Drug: Placebo
  • Experimental: LCZ696 200 mg
    Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
    Interventions:
    • Drug: LCZ696
    • Drug: Placebo
  • Experimental: LCZ696 400 mg
    Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
    Interventions:
    • Drug: LCZ696
    • Drug: Placebo
  • Active Comparator: Valsartan 80 mg
    Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
    Interventions:
    • Drug: Valsartan
    • Drug: Placebo
  • Active Comparator: Valsartan 160 mg
    Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsatan and AHU377 (5 tablets and 2 capsules) daily.
    Interventions:
    • Drug: Valsartan
    • Drug: Placebo
  • Active Comparator: Valsartan 320 mg
    Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
    Interventions:
    • Drug: Valsartan
    • Drug: Placebo
  • Experimental: AHU377 200 mg
    Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
    Interventions:
    • Drug: AHU377
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
    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:

  • 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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Canada,   Denmark,   Finland,   France,   Germany,   Hungary,   Italy,   Latvia,   Lithuania,   Netherlands,   Poland,   Russian Federation,   Slovakia,   Spain,   Sweden,   Taiwan
 
NCT00549770
CLCZ696A2201
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2015

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