Status:
COMPLETED
Combination of Telmisartan and Simvastatin in the Treatment of Hypertension and Hypercholesterolemia
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hypertension
Dyslipidemias
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will investigate two registered drugs, one for the treatment of high blood pressure and one for the treatment of elevated cholesterol. High blood pressure (hypertension) is a common medical...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
1695 Patients enrolled
Trial Details
Trial ID
NCT00316095
Start Date
April 1 2006
End Date
August 1 2007
Last Update
November 1 2013
Active Locations (92)
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1
Boehringer Ingelheim Investigational Site
Benátky nad Jizerou, Czechia, 294 71
2
Boehringer Ingelheim Investigational Site
Brno, Czechia, 65691
3
Boehringer Ingelheim Investigational Site
Mladá Boleslav, Czechia, 293 01
4
Boehringer Ingelheim Investigational Site
Pilsen, Czechia, 301 00