Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Combination of Telmisartan and Simvastatin in the Treatment of Hypertension and Hypercholesterolemia
