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

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