Clinical trial NCT00316095: Combination of Telmisartan and Simvastatin in the Treatment of Hypertension and Hypercholesterolemia
Official title: Reduced Factorial Design, Randomized, Double Blind Trial Comparing Combinations of Telmisartan 20 or 80 mg and Simvastatin 20 or 40 mg With Single Component Therapies in the Treatment of Hypertension and Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Dyslipidemias
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-04-20
Enrollment: 1695
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 condition affecting millions of people worldwide. A wide variety of effective drug treatments is available to reduce blood pressure. Elevated cholesterol (hypercholesterolemia) is a common medical condition affecting people worldwide. A wide variety of effective drug treatments is available to reduce cholesterol levels.

Hypertension and hypercholesterolemia often occur together. They are both important risk factors for the development of heart and vessel diseases (e.g. heart attack or stroke). Current guidelines advise treatment of high blood pressure and elevated cholesterol to reduce the risk of cardiovascular diseases. This study will test the simultaneous use of a drug to reduce blood pressure and a drug to reduce elevated cholesterol. Both drugs are registered and are effective. The drug for treatment of high blood pressure is telmisartan Micardis). The drug for treatment of elevated cholesterol is simvastatin (Zocor). Since hypertension and hypercholesterolemia frequently occur together, the purpose of this study is to investigate whether both drugs can be used simultaneously. A low dose and a high dose of these drugs will be used. It will be investigated whether each of the drugs is still as effective when given together, at the same time of day, with the other drug.


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

Primary outcomes:
measure: Change in 24-hour ambulatory blood pressure measurement (ABPM) measured mean diastolic blood pressure (DBP)
timeFrame: 8 weeks
measure: Change in 24-hour ambulatory blood pressure measurement (ABPM) measured mean low density lipoprotein (LDL)
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in the 24-hour ABPM (Ambulatory Blood Pressure Monitoring) measured mean SBP
timeFrame: after 8 weeks
measure: Changes in Trough-to-peak ratios of SBP and DBP, taken from ABPM
timeFrame: after 8 weeks
measure: Changes in Seated morning DBP and SBP
timeFrame: after 8 weeks
measure: Response rate to blood pressure treatment
timeFrame: after 8 weeks
measure: Response rate to lipid lowering treatment
timeFrame: after 8 weeks
measure: Change in Total cholesterol
timeFrame: after 8 weeks
measure: Change in HDL-cholesterol
timeFrame: after 8 weeks
measure: Change in triglycerides
timeFrame: after 8 weeks
measure: Change in Apolipoprotein B
timeFrame: after 8 weeks
measure: Change in free fatty acids
timeFrame: after 8 weeks
measure: Change in Adiponectin
timeFrame: after 8 weeks
measure: Change in HOMA-index
timeFrame: after 8 weeks
measure: Change in haemoglobin A1C
timeFrame: after 8 weeks
measure: Changes in high sensitive c-reactive protein
timeFrame: after 8 weeks
measure: Changes in microalbuminuria
timeFrame: after 8 weeks
measure: Adverse events
timeFrame: up to 15 weeks
measure: Changes in clinical laboratory parameter
timeFrame: up to 15 weeks
measure: Assessment of pulse rate
timeFrame: up to 15 weeks
Other outcomes:
Locations:
city: Benatky nad Jizerou
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site
city: Brno
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site
city: Mlada Boleslav
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site
city: Plzen
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site
city: Praha 5
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site
city: Pribram
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site
city: Unicov
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site
city: Usti nad Orlici
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site
city: Angers
country: France
facility: ALTI
city: Angers
country: France
facility: Boehringer Ingelheim Investigational Site
city: Sidi Daoud Tunis
country: France
facility: Boehringer Ingelheim Investigational Site
city: Tunis
country: France
facility: Boehringer Ingelheim Investigational Site
city: Haag
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Neuburg a. d. Donau
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Nurnberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Rednitzhembach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Unterschneidheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Westerkappeln
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wiesbaden
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wurzburg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hong Kong
country: Hong Kong
facility: Boehringer Ingelheim Investigational Site
city: Kwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Kyunggi-do
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Medical Center
city: Seoul
country: Korea, Republic of
facility: St. Mary Hospital
city: Almere
country: Netherlands
facility: Boehringer Ingelheim Investigational Site
city: Beek en Donk
country: Netherlands
facility: Boehringer Ingelheim Investigational Site
city: Breda
country: Netherlands
facility: Andromed Breda
city: Den Helder
country: Netherlands
facility: Gemini Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Andromed Eindhoven
city: Ewijk
country: Netherlands
facility: Boehringer Ingelheim Investigational Site
city: Groningen
country: Netherlands
facility: Andromed Noord
city: Leiden
country: Netherlands
facility: Andromed Leiden
city: Nijmegen
country: Netherlands
facility: Andromed Nijmegen
city: Oude Pekela
country: Netherlands
facility: Boehringer Ingelheim Investigational Site
city: Rotterdam
country: Netherlands
facility: Andromed Rotterdam
city: Utrecht
country: Netherlands
facility: Julius Center for Patient oriented Research
city: Velp
country: Netherlands
facility: Andromed Oost
city: Wildervank
country: Netherlands
facility: Boehringer Ingelheim Investigational Site
city: Zoetermeer
country: Netherlands
facility: Andromed Zoetermeer
city: Moscow
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: Boehringer Ingelheim Investigational Site
city: Kosice
country: Slovakia
facility: Boehringer Ingelheim Investigational Site
city: Kralovsky Chmlec
country: Slovakia
facility: Boehringer Ingelheim Investigational Site
city: Liptovsky Hradok
country: Slovakia
facility: Boehringer Ingelheim Investigational Site
city: Nitra
country: Slovakia
facility: Boehringer Ingelheim Investigational Site
city: Povazska Bystrica
country: Slovakia
facility: Boehringer Ingelheim Investigational Site
city: Presov
country: Slovakia
facility: Boehringer Ingelheim Investigational Site
city: Trencin
country: Slovakia
facility: Boehringer Ingelheim Investigational Site
city: Vrable
country: Slovakia
facility: Boehringer Ingelheim Investigational Site
city: Boksburg
country: South Africa
facility: Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: Boehringer Ingelheim Investigational Site
city: Durban
country: South Africa
facility: Boehringer Ingelheim Investigational Site
city: Johannesburg
country: South Africa
facility: Boehringer Ingelheim Investigational Site
city: Krugersdorp
country: South Africa
facility: Boehringer Ingelheim Investigational Site
city: Midrand
country: South Africa
facility: Boehringer Ingelheim Investigational Site
city: Goteborg
country: Sweden
facility: Medicinkliniken
city: Lule?
country: Sweden
facility: Medicinkliniken
city: Lule?
country: Sweden
facility: Boehringer Ingelheim Investigational Site
city: Malmo
country: Sweden
facility: Endokrinologkliniken
city: Rattvik
country: Sweden
facility: Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: Medicinkliniken
city: Uppsala
country: Sweden
facility: Boehringer Ingelheim Investigational Site
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Dnepropetrovsk
country: Ukraine
facility: Boehringer Ingelheim Investigational Site
city: Dnepropetrovsk
country: Ukraine
facility: Boehringer Ingelheim Investigational Site
city: Ivano-Frankovsk
country: Ukraine
facility: Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: Boehringer Ingelheim Investigational Site
city: Lutsk
country: Ukraine
facility: Boehringer Ingelheim Investigational Site
city: Lvov
country: Ukraine
facility: Boehringer Ingelheim Investigational Site
city: Lvov
country: Ukraine
facility: Boehringer Ingelheim Investigational Site
city: Zaporozhye
country: Ukraine
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim BV/Alkmaar
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: