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Combination of Telmisartan and Simvastatin in the Treatment of Hypertension and Hypercholesterolemia
This study has been completed.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00316095
  Purpose

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
Hypertension
Dyslipidemias
Drug: telmisartan
Drug: simvastatin
Phase III

Genetics Home Reference related topics: hypercholesterolemia
MedlinePlus related topics: Cholesterol High Blood Pressure
Drug Information available for: Simvastatin Telmisartan
U.S. FDA Resources
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

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary analysis will evaluate the efficacy of the combination treatments in reducing DBP and LDL-cholesterol. The primary objective is to demonstrate that the main effect of each component is non-inferior in the presence of the other component.

Secondary Outcome Measures:
  • The secondary objectives include changes from baseline to the end of trial with respect to blood pressure variables, lipid lowering treatment and evaluation of metabolic parameters and biomarkers of potential CV risk.

Estimated Enrollment: 1695
Estimated Study Completion Date: August 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to provide written informed consent
  • Age 18 years or older
  • Hypertension as defined by a mean seated cuff DBP of >=95 - 109 mmHg
  • Hypercholesterolemia as defined by a fasting LDL-C level at visit 2 according to
  • CV risk shown in table below:

    • CV Risk Group:

      1. Group I Hypertension and Hypercholesterolemia only
      2. Group II Hypertension and Hypercholesterolemia plus > 1 risk factors
      3. Group III Hypertension and Hypercholesterolemia plus CHD and/or diabetes mellitus and/or other athero-sclerotic disease
  • Fasting LDL-C group I and II: 100-250 mg/dL (2.6-6.5 mmol/L)
  • Fasting LDL-C group III: 100-160 mg/dL (2.6-4.1 mmol/L)
  • Risk factors: >= 45 yrs if male, >= 55 years if female, family history of CHD, current smoker, HDL-C < 40 mg/dL

Exclusion Criteria:

  • pre-menopausal women who are not surgically sterile or are nursing or pregnant or are of child-bearing potential and are not practicing acceptable means of birth control
  • inability to stop current antihypertensive and/or cholesterol-lowering therapies
  • contraindication to a washout/placebo treatment
  • clinically relevant cardiac arrhythmias
  • hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
  • mean sitting SBP >=180 mmHg or mean sitting DBP >=110 mmHg at two consecutive visits
  • known or suspected secondary hypertension
  • known or suspected secondary hyperlipidemia of any etiology
  • diabetes that has not been stable and controlled for the previous three months
  • severe renal dysfunction
  • bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or one kidney
  • biliary obstructive disorders, hepatic insufficiency, including past or current liver disease
  • clinically relevant hypokalaemia or hyperkalaemia
  • uncorrected volume depletion
  • uncorrected sodium depletion
  • any history of myopathy or rhabdomyolysis during the past treatment with HMG Co-A reductase inhibitors
  • concurrent use of large quantities of grapefruit juice
  • known hypersensitivity or intolerance to HMG Co-A reductase inhibitors and/or angiotensin receptor blockers, hereditary fructose intolerance
  • planned significant diet and/or lifestyle (including exercise) changes during the treatment phase of the trial
  • history of drug or alcohol dependency
  • any investigational drug therapy within one month of providing informed consent
  • any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316095

  Show 92 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim BV/Alkmaar
  More Information

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)

Study placed in the following topic categories:
Metabolic Diseases
Simvastatin
Vascular Diseases
Telmisartan
Angiotensin II
Metabolic disorder
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders
Hypertension

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009