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

About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
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: Group I Hypertension and Hypercholesterolemia only Group II Hypertension and Hypercholesterolemia plus > 1 risk factors 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
Sites / Locations
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- ALTI
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Chonnam National University Hospital
- Hallym University Sacred Heart Hospital
- Seoul National University Hospital
- Severance Hospital
- Korea University Medical Center
- St. Mary Hospital
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Andromed Breda
- Gemini Ziekenhuis
- Andromed Eindhoven
- Boehringer Ingelheim Investigational Site
- Andromed Noord
- Andromed Leiden
- Andromed Nijmegen
- Boehringer Ingelheim Investigational Site
- Andromed Rotterdam
- Julius Center for Patient oriented Research
- Andromed Oost
- Boehringer Ingelheim Investigational Site
- Andromed Zoetermeer
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Medicinkliniken
- Medicinkliniken
- Boehringer Ingelheim Investigational Site
- Endokrinologkliniken
- Boehringer Ingelheim Investigational Site
- Medicinkliniken
- Boehringer Ingelheim Investigational Site
- National Cheng Kung University Hospital
- Mackay Memorial Hospital
- Chang Gung Memorial Hospital
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site