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

NCT00316095 | Completed Phase 3

• 2 other identifiers: 1228.1EudraCT No.: 2005-002851-41
• Study Type: interventional
• Target: 1,695
• Locations: 12 countries
• Sites: 92

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

Outcome Measures

Primary Outcomes (2)

• Change in 24-hour ambulatory blood pressure measurement (ABPM) measured mean diastolic blood pressure (DBP)

  8 weeks

• Change in 24-hour ambulatory blood pressure measurement (ABPM) measured mean low density lipoprotein (LDL)

  8 weeks

Secondary Outcomes (18)

• Change in the 24-hour ABPM (Ambulatory Blood Pressure Monitoring) measured mean SBP

  after 8 weeks

• Changes in Trough-to-peak ratios of SBP and DBP, taken from ABPM

  after 8 weeks

• Changes in Seated morning DBP and SBP

  after 8 weeks

• Response rate to blood pressure treatment

  after 8 weeks

• Response rate to lipid lowering treatment

  after 8 weeks

Interventions

telmisartan DRUG

simvastatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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:
• 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

You may not qualify 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (92)

Boehringer Ingelheim Investigational Site

Benátky nad Jizerou, 294 71, Czechia

Location

Boehringer Ingelheim Investigational Site

Brno, 65691, Czechia

Location

Boehringer Ingelheim Investigational Site

Mladá Boleslav, 293 01, Czechia

Location

Boehringer Ingelheim Investigational Site

Pilsen, 301 00, Czechia

Location

Boehringer Ingelheim Investigational Site

Prague, 158 00, Czechia

Location

Boehringer Ingelheim Investigational Site

Příbram, 261 01, Czechia

Location

Boehringer Ingelheim Investigational Site

Uničov, 783 91, Czechia

Location

Boehringer Ingelheim Investigational Site

Ústí nad Orlicí, 562 18, Czechia

Location

ALTI

Angers, 49000, France

Location

Boehringer Ingelheim Investigational Site

Angers, 49000, France

Location

Boehringer Ingelheim Investigational Site

Sidi Daoud Tunis, 2046, France

Location

Boehringer Ingelheim Investigational Site

Tunis, 1089, France

Location

Boehringer Ingelheim Investigational Site

Haag, 83527, Germany

Location

Boehringer Ingelheim Investigational Site

Mainz, 55116, Germany

Location

Boehringer Ingelheim Investigational Site

Neuburg A. D. Donau, 86633, Germany

Location

Boehringer Ingelheim Investigational Site

Nuremberg, 90402, Germany

Location

Boehringer Ingelheim Investigational Site

Rednitzhembach, 91126, Germany

Location

Boehringer Ingelheim Investigational Site

Unterschneidheim, 73485, Germany

Location

Boehringer Ingelheim Investigational Site

Westerkappeln, 49492, Germany

Location

Boehringer Ingelheim Investigational Site

Wiesbaden, 65191, Germany

Location

Boehringer Ingelheim Investigational Site

Würzburg, 97072, Germany

Location

Boehringer Ingelheim Investigational Site

Hong Kong, Hong Kong

Location

Boehringer Ingelheim Investigational Site

Almere Stad, 1311RL, Netherlands

Location

Boehringer Ingelheim Investigational Site

Beek en Donk, 5741 CG, Netherlands

Location

Andromed Breda

Breda, 4811 VL, Netherlands

Location

Gemini Ziekenhuis

Den Helder, 1782 GZ, Netherlands

Location

Andromed Eindhoven

Eindhoven, 5611 NJ, Netherlands

Location

Boehringer Ingelheim Investigational Site

Ewijk, 6644 CL, Netherlands

Location

Andromed Noord

Groningen, 9711 SG, Netherlands

Location

Andromed Leiden

Leiden, 2311 GZ, Netherlands

Location

Andromed Nijmegen

Nijmegen, 6533 HL, Netherlands

Location

Boehringer Ingelheim Investigational Site

Oude Pekela, 9665 BJ, Netherlands

Location

Andromed Rotterdam

Rotterdam, 3021 HC, Netherlands

Location

Julius Center for Patient oriented Research

Utrecht, 3584 CJ, Netherlands

Location

Andromed Oost

Velp, 6883 ES, Netherlands

Location

Boehringer Ingelheim Investigational Site

Wildervank, 9648 BE, Netherlands

Location

Andromed Zoetermeer

Zoetermeer, 2724 EK, Netherlands

Location

Boehringer Ingelheim Investigational Site

Moscow, 101990, Russia

Location

Boehringer Ingelheim Investigational Site

Moscow, 117036, Russia

Location

Boehringer Ingelheim Investigational Site

Moscow, 119992, Russia

Location

Boehringer Ingelheim Investigational Site

Moscow, 121356, Russia

Location

Boehringer Ingelheim Investigational Site

Moscow, 121552, Russia

Location

Boehringer Ingelheim Investigational Site

Moscow, 127018, Russia

Location

Boehringer Ingelheim Investigational Site

Moscow, 129010, Russia

Location

Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

Boehringer Ingelheim Investigational Site

Saint Petersburg, 195257, Russia

Location

Boehringer Ingelheim Investigational Site

Saint Petersburg, 198013, Russia

Location

Boehringer Ingelheim Investigational Site

Bratislava, 82606, Slovakia

Location

Boehringer Ingelheim Investigational Site

Košice, 040 01, Slovakia

Location

Boehringer Ingelheim Investigational Site

Kralovsky Chmlec, 077 01, Slovakia

Location

Boehringer Ingelheim Investigational Site

Liptovský Hrádok, 033 01, Slovakia

Location

Boehringer Ingelheim Investigational Site

Nitra, 950 01, Slovakia

Location

Boehringer Ingelheim Investigational Site

Považská Bystrica, 017 01, Slovakia

Location

Boehringer Ingelheim Investigational Site

Prešov, 081 81, Slovakia

Location

Boehringer Ingelheim Investigational Site

Trenčín, 911 05, Slovakia

Location

Boehringer Ingelheim Investigational Site

Vráble, 952 01, Slovakia

Location

Boehringer Ingelheim Investigational Site

Boksburg, 1461, South Africa

Location

Boehringer Ingelheim Investigational Site

Cape Town, 7405, South Africa

Location

Boehringer Ingelheim Investigational Site

Cape Town, 7925, South Africa

Location

Boehringer Ingelheim Investigational Site

Durban, 4091, South Africa

Location

Boehringer Ingelheim Investigational Site

Johannesburg, 2033, South Africa

Location

Boehringer Ingelheim Investigational Site

Krugersdorp, 1739, South Africa

Location

Boehringer Ingelheim Investigational Site

Midrand, 1685, South Africa

Location

Chonnam National University Hospital

Kwangju, 501757, South Korea

Location

Hallym University Sacred Heart Hospital

Kyunggi-do, 431070, South Korea

Location

Seoul National University Hospital

Seoul, 110774, South Korea

Location

Severance Hospital

Seoul, 120752, South Korea

Location

Korea University Medical Center

Seoul, 136705, South Korea

Location

St. Mary Hospital

Seoul, 150713, South Korea

Location

Medicinkliniken

Gothenburg, 416 85, Sweden

Location

Medicinkliniken

Lule?, 971 80, Sweden

Location

Boehringer Ingelheim Investigational Site

Lule?, S-971 31, Sweden

Location

Endokrinologkliniken

Malmo, 205 02, Sweden

Location

Boehringer Ingelheim Investigational Site

Rättvik, 795 33, Sweden

Location

Medicinkliniken

Stockholm, 182 88, Sweden

Location

Boehringer Ingelheim Investigational Site

Uppsala, S-752 23, Sweden

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Mackay Memorial Hospital

Taipei, 104, Taiwan

Location

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Boehringer Ingelheim Investigational Site

Dnipro, 49006, Ukraine

Location

Boehringer Ingelheim Investigational Site

Dnipro, 49023, Ukraine

Location

Boehringer Ingelheim Investigational Site

Ivano-Frankivsk, 76000, Ukraine

Location

Boehringer Ingelheim Investigational Site

Kharkiv, 61018, Ukraine

Location

Boehringer Ingelheim Investigational Site

Kharkiv, 61037, Ukraine

Location

Boehringer Ingelheim Investigational Site

Kiev, 02175, Ukraine

Location

Boehringer Ingelheim Investigational Site

Kiev, 03151, Ukraine

Location

Boehringer Ingelheim Investigational Site

Kiev, 03680, Ukraine

Location

Boehringer Ingelheim Investigational Site

Kiev, 04114, Ukraine

Location

Boehringer Ingelheim Investigational Site

Lutsk, 43024, Ukraine

Location

Boehringer Ingelheim Investigational Site

Lviv, 73013, Ukraine

Location

Boehringer Ingelheim Investigational Site

Lviv, 79015, Ukraine

Location

Boehringer Ingelheim Investigational Site

Zaporizhzhya, 69035, Ukraine

Location

MeSH Terms

Conditions

Hypertension; Dyslipidemias

Interventions

Telmisartan; Simvastatin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Boehringer Ingelheim Study Coordinator

  Boehringer Ingelheim BV/Alkmaar

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 19, 2006
• First Posted: April 20, 2006
• Study Start: April 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

DE (9); CZ (8); FR (4); SL (9); KR (6); SE (7); NL (15); HK (1); RU (10); ZA (7); TW (3); UA (13)