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

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Hypertension

Dyslipidemias

Treatments

Drug: telmisartan

Drug: simvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00316095

EudraCT No.: 2005-002851-41

1228.1

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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