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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00887588 |
The study will assess the effects of 12 weeks of treatment with LCZ696 compared to valsartan on N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) in patients with chronic heart failure and preserved left-ventricular ejection fraction.
Condition | Intervention | Phase |
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Chronic Heart Failure |
Drug: LCZ696 Drug: Valsartan |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
Official Title: | A Twelve-Week, Randomized, Double-Blind, Multi-Center, Parallel Group, Active Controlled Study to Evaluate the Efficacy, Safety and Tolerability of LCZ696 Compared to Valsartan in Patients With Chronic Heart Failure and Preserved Left-Ventricular Ejection Fraction |
Estimated Enrollment: | 290 |
Study Start Date: | June 2009 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
LCZ696 50 mg titrated to 100 mg and 200 mg
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Drug: LCZ696
LCZ696 50 mg titrated to 100 mg and 200 mg
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2: Active Comparator
Valsartan 40 mg titrated to 80 mg and 160 mg
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Drug: Valsartan
Valsartan 40 mg titrated to 80 mg and 160 mg
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Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with documented stable chronic heart failure (NYHA II-IV):
control BP at randomization (Visit 2).
Patients with at least one of the following symptoms at the time of screening (Visit 1):
Exclusion Criteria:
Contact: Novartis | 862-778-8300 |
United States, Illinois | |
Investigator Site | |
Chicago, Illinois, United States, 60657 | |
Argentina | |
Investigative Site | |
Buenos Aires, Argentina | |
Brazil | |
Investigative Site | |
São Paulo, Brazil | |
Canada, Quebec | |
Investigative Site | |
Montreal, Quebec, Canada | |
India | |
Investigative Site | |
Mumbai, India | |
Italy | |
Investigative Site | |
Cosenza, Italy | |
Netherlands | |
Investigative Site | |
Amsterdam, Netherlands | |
Poland | |
Investigative Site | |
Wrocław, Poland | |
Romania | |
Investigative Site | |
Baia Mare, Romania | |
Russian Federation | |
Investigative Site | |
Moscow, Russian Federation | |
Singapore | |
Investigative Site | |
Singapore, Singapore | |
Spain | |
Investigative Site | |
Madrid, Spain | |
Venezuela | |
Investigative Site | |
Caracas, Venezuela |
Study Director: | Novartis | Novartis |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | LCZ696B2214 |
Study First Received: | April 22, 2009 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00887588 History of Changes |
Health Authority: | Argentina: Ministry of Health; Brazil: Ministry of Health; Canada: Health Canada; India: Ministry of Health; Italy: Ministry of Health; Netherlands: Medicines Evaluation Board (MEB); Poland: Ministry of Health; Romania: Ministry of Public Health; Russia: Pharmacological Committee, Ministry of Health; Singapore: Health Sciences Authority; Spain: Ministry of Health; United States: Food and Drug Administration; Venezuela: Ministry of Health |
Chronic heart failure preserved ejection fraction cardiovascular disease NT-proBNP |
biomarkers Heart failure with preserved left-ventricular ejection fraction |
Heart Failure Heart Diseases Cardiovascular Agents Antihypertensive Agents Valsartan |
Heart Failure Heart Diseases Therapeutic Uses Cardiovascular Diseases |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Valsartan |