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

NCT ID: NCT00316095

Last Updated: 2013-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1695 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-08-31

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.

Conditions

Hypertension; Dyslipidemias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

telmisartan

Intervention Type: DRUG

simvastatin

Intervention Type: 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Principal Investigators

Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

Boehringer Ingelheim BV/Alkmaar

Locations

Boehringer Ingelheim Investigational Site

Benátky nad Jizerou, , Czechia

Boehringer Ingelheim Investigational Site

Brno, , Czechia

Boehringer Ingelheim Investigational Site

Mladá Boleslav, , Czechia

Boehringer Ingelheim Investigational Site

Pilsen, , Czechia

Boehringer Ingelheim Investigational Site

Prague, , Czechia

Boehringer Ingelheim Investigational Site

Příbram, , Czechia

Boehringer Ingelheim Investigational Site

Uničov, , Czechia

Boehringer Ingelheim Investigational Site

Ústí nad Orlicí, , Czechia

ALTI

Angers, , France

Boehringer Ingelheim Investigational Site

Angers, , France

Boehringer Ingelheim Investigational Site

Sidi Daoud Tunis, , France

Boehringer Ingelheim Investigational Site

Tunis, , France

Boehringer Ingelheim Investigational Site

Haag, , Germany

Boehringer Ingelheim Investigational Site

Mainz, , Germany

Boehringer Ingelheim Investigational Site

Neuburg A. D. Donau, , Germany

Boehringer Ingelheim Investigational Site

Nuremberg, , Germany

Boehringer Ingelheim Investigational Site

Rednitzhembach, , Germany

Boehringer Ingelheim Investigational Site

Unterschneidheim, , Germany

Boehringer Ingelheim Investigational Site

Westerkappeln, , Germany

Boehringer Ingelheim Investigational Site

Wiesbaden, , Germany

Boehringer Ingelheim Investigational Site

Würzburg, , Germany

Boehringer Ingelheim Investigational Site

Hong Kong, , Hong Kong

Boehringer Ingelheim Investigational Site

Almere Stad, , Netherlands

Boehringer Ingelheim Investigational Site

Beek en Donk, , Netherlands

Andromed Breda

Breda, , Netherlands

Gemini Ziekenhuis

Den Helder, , Netherlands

Andromed Eindhoven

Eindhoven, , Netherlands

Boehringer Ingelheim Investigational Site

Ewijk, , Netherlands

Andromed Noord

Groningen, , Netherlands

Andromed Leiden

Leiden, , Netherlands

Andromed Nijmegen

Nijmegen, , Netherlands

Boehringer Ingelheim Investigational Site

Oude Pekela, , Netherlands

Andromed Rotterdam

Rotterdam, , Netherlands

Julius Center for Patient oriented Research

Utrecht, , Netherlands

Andromed Oost

Velp, , Netherlands

Boehringer Ingelheim Investigational Site

Wildervank, , Netherlands

Andromed Zoetermeer

Zoetermeer, , Netherlands

Boehringer Ingelheim Investigational Site

Moscow, , Russia

Boehringer Ingelheim Investigational Site

Moscow, , Russia

Boehringer Ingelheim Investigational Site

Moscow, , Russia

Boehringer Ingelheim Investigational Site

Moscow, , Russia

Boehringer Ingelheim Investigational Site

Moscow, , Russia

Boehringer Ingelheim Investigational Site

Moscow, , Russia

Boehringer Ingelheim Investigational Site

Moscow, , Russia

Boehringer Ingelheim Investigational Site

Moscow, , Russia

Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

Boehringer Ingelheim Investigational Site

Košice, , Slovakia

Boehringer Ingelheim Investigational Site

Kralovsky Chmlec, , Slovakia

Boehringer Ingelheim Investigational Site

Liptovský Hrádok, , Slovakia

Boehringer Ingelheim Investigational Site

Nitra, , Slovakia

Boehringer Ingelheim Investigational Site

Považská Bystrica, , Slovakia

Boehringer Ingelheim Investigational Site

Prešov, , Slovakia

Boehringer Ingelheim Investigational Site

Trenčín, , Slovakia

Boehringer Ingelheim Investigational Site

Vráble, , Slovakia

Boehringer Ingelheim Investigational Site

Boksburg, , South Africa

Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

Boehringer Ingelheim Investigational Site

Durban, , South Africa

Boehringer Ingelheim Investigational Site

Johannesburg, , South Africa

Boehringer Ingelheim Investigational Site

Krugersdorp, , South Africa

Boehringer Ingelheim Investigational Site

Midrand, , South Africa

Chonnam National University Hospital

Kwangju, , South Korea

Hallym University Sacred Heart Hospital

Kyunggi-do, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

Korea University Medical Center

Seoul, , South Korea

St. Mary Hospital

Seoul, , South Korea

Medicinkliniken

Gothenburg, , Sweden

Medicinkliniken

Lule?, , Sweden

Boehringer Ingelheim Investigational Site

Lule?, , Sweden

Endokrinologkliniken

Malmo, , Sweden

Boehringer Ingelheim Investigational Site

Rättvik, , Sweden

Medicinkliniken

Stockholm, , Sweden

Boehringer Ingelheim Investigational Site

Uppsala, , Sweden

National Cheng Kung University Hospital

Tainan City, , Taiwan

Mackay Memorial Hospital

Taipei, , Taiwan

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Boehringer Ingelheim Investigational Site

Dnipro, , Ukraine

Boehringer Ingelheim Investigational Site

Dnipro, , Ukraine

Boehringer Ingelheim Investigational Site

Ivano-Frankivsk, , Ukraine

Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Boehringer Ingelheim Investigational Site

Lutsk, , Ukraine

Boehringer Ingelheim Investigational Site

Lviv, , Ukraine

Boehringer Ingelheim Investigational Site

Lviv, , Ukraine

Boehringer Ingelheim Investigational Site

Zaporizhzhya, , Ukraine

Countries

China; Hungary; Czechia; France; Germany; Hong Kong; Netherlands; Russia; Slovakia; South Africa; South Korea; Sweden; Taiwan; Ukraine

Other Identifiers

EudraCT No.: 2005-002851-41

Identifier Type: -

Identifier Source: secondary_id

1228.1

Identifier Type: -

Identifier Source: org_study_id