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

Condition(s) targeted: Hypertension; Dyslipidemias

Intervention: telmisartan (Drug); simvastatin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim BV/Alkmaar

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.

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study

Primary outcome: The primary analysis will evaluate the efficacy of the combination treatments in reducing DBP and LDL-cholesterol. The primary objective is to demonstrate that the main effect of each component is non-inferior in the presence of the other component.

Secondary outcome: The secondary objectives include changes from baseline to the end of trial with respect to blood pressure variables, lipid lowering treatment and evaluation of metabolic parameters and biomarkers of potential CV risk.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Boehringer Ingelheim Investigational Site, Usti nad Orlici 562 18, Czech Republic

Boehringer Ingelheim Investigational Site, Unicov 783 91, Czech Republic

Boehringer Ingelheim Investigational Site, Pribram 261 01, Czech Republic

Boehringer Ingelheim Investigational Site, Benatky nad Jizerou 294 71, Czech Republic

Boehringer Ingelheim Investigational Site, Mlada Boleslav 293 01, Czech Republic

Boehringer Ingelheim Investigational Site, Plzen 301 00, Czech Republic

Boehringer Ingelheim Investigational Site, Praha 5 158 00, Czech Republic

Boehringer Ingelheim Investigational Site, Brno 65691, Czech Republic

Boehringer Ingelheim Investigational Site, Angers 49000, France

ALTI, Angers 49000, France

Boehringer Ingelheim Investigational Site, Sidi Daoud Tunis 2046, France

Boehringer Ingelheim Investigational Site, Tunis 1089, France

Boehringer Ingelheim Investigational Site, Mainz 55116, Germany

Boehringer Ingelheim Investigational Site, Neuburg a. d. Donau 86633, Germany

Boehringer Ingelheim Investigational Site, Rednitzhembach 91126, Germany

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Boehringer Ingelheim Investigational Site, Nurnberg 90402, Germany

Boehringer Ingelheim Investigational Site, Westerkappeln 49492, Germany

Boehringer Ingelheim Investigational Site, Unterschneidheim 73485, Germany

Boehringer Ingelheim Investigational Site, Wiesbaden 65191, Germany

Boehringer Ingelheim Investigational Site, Hong Kong, Hong Kong

Severance Hospital, Seoul 120752, Korea, Republic of

Korea University Medical Center, Seoul 136705, Korea, Republic of

St. Mary Hospital, Seoul 150713, Korea, Republic of

Seoul National University Hospital, Seoul 110774, Korea, Republic of

Hallym University Sacred Heart Hospital, Kyunggi-do 431070, Korea, Republic of

Chonnam National University Hospital, Kwangju 501757, Korea, Republic of

Andromed Rotterdam, Rotterdam 3021 HC, Netherlands

Andromed Noord, Groningen 9711 SG, Netherlands

Andromed Nijmegen, Nijmegen 6533 HL, Netherlands

Andromed Oost, Velp 6883 ES, Netherlands

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Andromed Breda, Breda 4811 VL, Netherlands

Andromed Leiden, Leiden 2311 GZ, Netherlands

Andromed Zoetermeer, Zoetermeer 2724 EK, Netherlands

Boehringer Ingelheim Investigational Site, Almere 1311RL, Netherlands

Julius Center for Patient oriented Research, Utrecht 3584 CJ, Netherlands

Gemini Ziekenhuis, Den Helder 1782 GZ, Netherlands

Boehringer Ingelheim Investigational Site, Oude Pekela 9665 BJ, Netherlands

Boehringer Ingelheim Investigational Site, Ewijk 6644 CL, Netherlands

Boehringer Ingelheim Investigational Site, Beek en Donk 5741 CG, Netherlands

Boehringer Ingelheim Investigational Site, Wildervank 9648 BE, Netherlands

Boehringer Ingelheim Investigational Site, St. Petersburg 195257, Russian Federation

Boehringer Ingelheim Investigational Site, St. Petersburg 198013, Russian Federation

Boehringer Ingelheim Investigational Site, Moscow 129010, Russian Federation

Boehringer Ingelheim Investigational Site, Moscow 117036, Russian Federation

Boehringer Ingelheim Investigational Site, Moscow, Russian Federation

Boehringer Ingelheim Investigational Site, Moscow 127018, Russian Federation

Boehringer Ingelheim Investigational Site, Moscow 101990, Russian Federation

Boehringer Ingelheim Investigational Site, Moscow 121552, Russian Federation

Boehringer Ingelheim Investigational Site, Moscow 119992, Russian Federation

Boehringer Ingelheim Investigational Site, Moscow 121356, Russian Federation

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Boehringer Ingelheim Investigational Site, Vrable 952 01, Slovakia

Boehringer Ingelheim Investigational Site, Liptovsky Hradok 033 01, Slovakia

Boehringer Ingelheim Investigational Site, Kralovsky Chmlec 077 01, Slovakia

Boehringer Ingelheim Investigational Site, Kosice 040 01, Slovakia

Boehringer Ingelheim Investigational Site, Trencin 911 05, Slovakia

Boehringer Ingelheim Investigational Site, Presov 081 81, Slovakia

Boehringer Ingelheim Investigational Site, Povazska Bystrica 017 01, Slovakia

Boehringer Ingelheim Investigational Site, Bratislava 82606, Slovakia

Boehringer Ingelheim Investigational Site, Johannesburg 2033, South Africa

Boehringer Ingelheim Investigational Site, Boksburg 1461, South Africa

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Boehringer Ingelheim Investigational Site, Krugersdorp 1739, South Africa

Boehringer Ingelheim Investigational Site, Cape Town 7925, South Africa

Boehringer Ingelheim Investigational Site, Midrand 1685, South Africa

Boehringer Ingelheim Investigational Site, Cape Town 7405, South Africa

Medicinkliniken, Goteborg 416 85, Sweden

Medicinkliniken, Stockholm 182 88, Sweden

Medicinkliniken, Lule? 971 80, Sweden

Endokrinologkliniken, Malmo 205 02, Sweden

Boehringer Ingelheim Investigational Site, Uppsala S-752 23, Sweden

Boehringer Ingelheim Investigational Site, Lule? S-971 31, Sweden

Boehringer Ingelheim Investigational Site, Rattvik 795 33, Sweden

National Cheng Kung University Hospital, Tainan 704, Taiwan

Mackay Memorial Hospital, Taipei 104, Taiwan

Chang Gung Memorial Hospital, Taoyuan 333, Taiwan

Boehringer Ingelheim Investigational Site, Kiev 04114, Ukraine

Boehringer Ingelheim Investigational Site, Lvov 79015, Ukraine

Boehringer Ingelheim Investigational Site, Lvov 73013, Ukraine

Boehringer Ingelheim Investigational Site, Dnepropetrovsk 49006, Ukraine

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Boehringer Ingelheim Investigational Site, Zaporozhye 69035, Ukraine

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Ending date: August 2007
Last updated: June 11, 2008