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Combination of Telmisartan and Simvastatin in the Treatment of Hypertension and Hypercholesterolemia

This study has been completed.
Information provided by:
Boehringer Ingelheim Identifier:
First received: April 19, 2006
Last updated: October 31, 2013
Last verified: October 2013

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
Drug: telmisartan
Drug: simvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change in 24-hour ambulatory blood pressure measurement (ABPM) measured mean diastolic blood pressure (DBP) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in 24-hour ambulatory blood pressure measurement (ABPM) measured mean low density lipoprotein (LDL) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in the 24-hour ABPM (Ambulatory Blood Pressure Monitoring) measured mean SBP [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Changes in Trough-to-peak ratios of SBP and DBP, taken from ABPM [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Changes in Seated morning DBP and SBP [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Response rate to blood pressure treatment [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Response rate to lipid lowering treatment [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Change in Total cholesterol [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Change in HDL-cholesterol [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Change in triglycerides [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Change in Apolipoprotein B [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Change in free fatty acids [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Change in Adiponectin [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Change in HOMA-index [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Change in haemoglobin A1C [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Changes in high sensitive c-reactive protein [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Changes in microalbuminuria [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
  • Changes in clinical laboratory parameter [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
  • Assessment of pulse rate [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1695
Study Start Date: April 2006
Estimated Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00316095

  Show 92 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim BV/Alkmaar
  More Information Identifier: NCT00316095     History of Changes
Other Study ID Numbers: 1228.1  EudraCT No.: 2005-002851-41 
Study First Received: April 19, 2006
Last Updated: October 31, 2013
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: 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)

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists processed this record on January 17, 2017