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Sponsored by: |
Novartis Pharmaceuticals |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00549770 |
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.
Condition | Intervention | Phase |
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Hypertension |
Drug: LCZ696 Drug: Valsartan Drug: AHU377 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 1334 |
Study Start Date: | September 2007 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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LCZ696 (Dose 1): Experimental | Drug: LCZ696 |
LCZ696 (Dose 2): Experimental | Drug: LCZ696 |
LCZ696 (Dose 3): Experimental | Drug: LCZ696 |
Valsartan (Dose 1): Active Comparator | Drug: Valsartan |
Valsartan (Dose 2): Active Comparator | Drug: Valsartan |
Valsartan (Dose 3): Active Comparator | Drug: Valsartan |
AHU377: Experimental | Drug: AHU377 |
Placebo: Placebo Comparator | Drug: Placebo |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New Jersey | |
Novartis | |
East Hanover, New Jersey, United States, 07936 | |
Germany | |
Sites in Germany | |
Sites in Germany, Germany |
Study Chair: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CLCZ696A2201 |
Study First Received: | October 5, 2007 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00549770 History of Changes |
Health Authority: | United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Canada: Health Canada; Denmark: Danish Health Authorities; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Italy: The Italian Medicines Agency; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Poland: Centralna Ewidencja Badan Klinicznych; Russia: Federal Service of the Russian Federation for Supervision in the Sphere of Public Health and Social Development; Slovakia: State Institute for Drug Control; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Taiwan: Department of Health |
Hypertension, valsartan, LCZ696 |
Essential Hypertension Vascular Diseases Cardiovascular Agents |
Antihypertensive Agents Valsartan Hypertension |
Therapeutic Uses Vascular Diseases Cardiovascular Diseases Cardiovascular Agents |
Antihypertensive Agents Pharmacologic Actions Valsartan Hypertension |