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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00316095
Recruitment Status : Completed
First Posted : April 20, 2006
Last Update Posted : November 1, 2013
Information provided by:
Boehringer Ingelheim

Brief Summary:

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 or disease Intervention/treatment Phase
Hypertension Dyslipidemias Drug: telmisartan Drug: simvastatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1695 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
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
Study Start Date : April 2006
Actual Primary Completion Date : August 2007
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change in 24-hour ambulatory blood pressure measurement (ABPM) measured mean diastolic blood pressure (DBP) [ Time Frame: 8 weeks ]
  2. Change in 24-hour ambulatory blood pressure measurement (ABPM) measured mean low density lipoprotein (LDL) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Change in the 24-hour ABPM (Ambulatory Blood Pressure Monitoring) measured mean SBP [ Time Frame: after 8 weeks ]
  2. Changes in Trough-to-peak ratios of SBP and DBP, taken from ABPM [ Time Frame: after 8 weeks ]
  3. Changes in Seated morning DBP and SBP [ Time Frame: after 8 weeks ]
  4. Response rate to blood pressure treatment [ Time Frame: after 8 weeks ]
  5. Response rate to lipid lowering treatment [ Time Frame: after 8 weeks ]
  6. Change in Total cholesterol [ Time Frame: after 8 weeks ]
  7. Change in HDL-cholesterol [ Time Frame: after 8 weeks ]
  8. Change in triglycerides [ Time Frame: after 8 weeks ]
  9. Change in Apolipoprotein B [ Time Frame: after 8 weeks ]
  10. Change in free fatty acids [ Time Frame: after 8 weeks ]
  11. Change in Adiponectin [ Time Frame: after 8 weeks ]
  12. Change in HOMA-index [ Time Frame: after 8 weeks ]
  13. Change in haemoglobin A1C [ Time Frame: after 8 weeks ]
  14. Changes in high sensitive c-reactive protein [ Time Frame: after 8 weeks ]
  15. Changes in microalbuminuria [ Time Frame: after 8 weeks ]
  16. Adverse events [ Time Frame: up to 15 weeks ]
  17. Changes in clinical laboratory parameter [ Time Frame: up to 15 weeks ]
  18. Assessment of pulse rate [ Time Frame: up to 15 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00316095

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Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim BV/Alkmaar
Layout table for additonal information Identifier: NCT00316095    
Other Study ID Numbers: 1228.1
EudraCT No.: 2005-002851-41
First Posted: April 20, 2006    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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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