Clinical trial NCT00316095 (phase 3, status: completed)
Conditions: hypertension, dyslipidemias
ICD codes: I15.0, I97.3, K76.6, P29.2, G93.2, H40.053, I10
Drugs: telmisartan, simvastatin
SMILES: CCCC1=NC2=C(C=C(C=C2C)C2=NC3=CC=CC=C3N2C)N1CC1=CC=C(C=C1)C1=CC=CC=C1C(O)=O, CC1=CC(O)=CC(C)=C1Cl
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:

                    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