Efficacy and Safety of LCZ696A in Patients With Essential Hypertension
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00549770
First received: October 5, 2007
Last updated: August 30, 2010
Last verified: August 2010
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Purpose
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 |
|---|---|---|
|
Hypertension |
Drug: LCZ696 Drug: Valsartan Drug: AHU377 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
High Blood Pressure
Drug Information available for:
Valsartan
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Mean sitting diastolic blood pressure change of LCZ696 compared to valsartan [ Time Frame: from baseline to week 8 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- MSSBP/MSDBP change of LCZ696 compared to placebo [ Time Frame: baseline to week 8 ] [ Designated as safety issue: No ]
| 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 |
|---|---|
| Experimental: LCZ696 (Dose 1) | Drug: LCZ696 |
| Experimental: LCZ696 (Dose 2) | Drug: LCZ696 |
| Experimental: LCZ696 (Dose 3) | Drug: LCZ696 |
| Active Comparator: Valsartan (Dose 1) | Drug: Valsartan |
| Active Comparator: Valsartan (Dose 2) | Drug: Valsartan |
| Active Comparator: Valsartan (Dose 3) | Drug: Valsartan |
| Experimental: AHU377 | Drug: AHU377 |
| Placebo Comparator: Placebo | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549770
Locations
| United States, New Jersey | |
| Novartis | |
| East Hanover, New Jersey, United States, 07936 | |
| Germany | |
| Sites in Germany | |
| Sites in Germany, Germany | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Chair: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided by Novartis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00549770 History of Changes |
| Other Study ID Numbers: | CLCZ696A2201 |
| Study First Received: | October 5, 2007 |
| Last Updated: | August 30, 2010 |
| 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: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) 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: The Central Register of Clinical Trials Russia: Ministry of Health of the Russian Federation Slovakia: State Institute for Drug Control Spain: Spanish Agency of Medicines Sweden: Medical Products Agency Taiwan: Department of Health |
Keywords provided by Novartis:
|
Hypertension, valsartan, LCZ696 |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Valsartan Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013