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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00316095 |
This study will investigate two registered drugs, one for the treatment of high blood pressure and one for the treatment of elevated cholesterol. High blood pressure (hypertension) is a common medical condition affecting millions of people worldwide. A wide variety of effective drug treatments is available to reduce blood pressure. Elevated cholesterol (hypercholesterolemia) is a common medical condition affecting people worldwide. A wide variety of effective drug treatments is available to reduce cholesterol levels.
Hypertension and hypercholesterolemia often occur together. They are both important risk factors for the development of heart and vessel diseases (e.g. heart attack or stroke). Current guidelines advise treatment of high blood pressure and elevated cholesterol to reduce the risk of cardiovascular diseases. This study will test the simultaneous use of a drug to reduce blood pressure and a drug to reduce elevated cholesterol. Both drugs are registered and are effective. The drug for treatment of high blood pressure is telmisartan Micardis). The drug for treatment of elevated cholesterol is simvastatin (Zocor). Since hypertension and hypercholesterolemia frequently occur together, the purpose of this study is to investigate whether both drugs can be used simultaneously. A low dose and a high dose of these drugs will be used. It will be investigated whether each of the drugs is still as effective when given together, at the same time of day, with the other drug.
Condition | Intervention | Phase |
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Hypertension Dyslipidemias |
Drug: telmisartan Drug: simvastatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Reduced Factorial Design, Randomized, Double Blind Trial Comparing Combinations of Telmisartan 20 or 80 mg and Simvastatin 20 or 40 mg With Single Component Therapies in the Treatment of Hypertension and Dyslipidemia |
Estimated Enrollment: | 1695 |
Estimated Study Completion Date: | August 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
CV risk shown in table below:
CV Risk Group:
Exclusion Criteria:
Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim BV/Alkmaar |
Study ID Numbers: | 1228.1, EudraCT No.: 2005-002851-41 |
Study First Received: | April 19, 2006 |
Last Updated: | June 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00316095 |
Health Authority: | Netherlands: Commissie Mensgebonden Onderzoek (CCMO); Austria: Ministry of Healthcare and Social Development of Russian Federation, Moscow; Austria: Ministry of Health Crae of Ukraine (MoH of Ukraine); France: Agence Francaise de Securite Sanitaire des Produits de Sante; Sweden: Medical Products Agency; South Africa: Medicines Control Council (MCC); Taiwan: Department of Health, Executive Yuan, ROC; Hong Kong: Department of Health Pharmaceuticals Registration and Import / Export Central Section; Germany: BfArM (Bundesagentur fuer Arzneimittel und Medizinalprodukte); China: State Food and Drug Administration; Korea, Republic of: Korea Food and Drug Administration; Austria: SUKL (state institute for drug control); Austria: State Institute for Drug Control (SUKL) |
Metabolic Diseases Simvastatin Vascular Diseases Telmisartan Angiotensin II |
Metabolic disorder Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders Hypertension |
Angiotensin II Type 1 Receptor Blockers Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents Angiotensin-Converting Enzyme Inhibitors |
Enzyme Inhibitors Cardiovascular Diseases Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Protease Inhibitors |