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

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