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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: telmisartan
• Drug: simvastatin

Primary 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 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.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Coordinator Study Chair Boehringer Ingelheim BV/Alkmaar  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00316095

Study ID Number: 1228.1

ClinicalTrials.gov Identifier: NCT00316095

Health Authority: Netherlands: Commissie Mensgebonden Onderzoek (CCMO)