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

Phase 3

Completed

• Conditions: Hypertension; Dyslipidemias

• Registration Number: NCT00316095
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-19
• Study First Submitted QC: 2006-04-19
• Study First Posted: 2006-04-20
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1695

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Changes in Trough-to-peak ratios of SBP and DBP, taken from ABPM	after 8 weeks
Response rate to blood pressure treatment	after 8 weeks
Response rate to lipid lowering treatment	after 8 weeks
Change in Apolipoprotein B	after 8 weeks
Change in Adiponectin	after 8 weeks
Changes in Seated morning DBP and SBP	after 8 weeks
Change in HDL-cholesterol	after 8 weeks
Changes in microalbuminuria	after 8 weeks
Changes in clinical laboratory parameter	up to 15 weeks
Change in the 24-hour ABPM (Ambulatory Blood Pressure Monitoring) measured mean SBP	after 8 weeks
Change in Total cholesterol	after 8 weeks
Change in triglycerides	after 8 weeks
Change in free fatty acids	after 8 weeks
Change in HOMA-index	after 8 weeks
Change in haemoglobin A1C	after 8 weeks
Changes in high sensitive c-reactive protein	after 8 weeks
Adverse events	up to 15 weeks
Assessment of pulse rate	up to 15 weeks

Trial Locations

Locations (23)

ALTI; 🇫🇷 Angers, France

Hallym University Sacred Heart Hospital; 🇰🇷 Kyunggi-do, Korea, Republic of

Andromed Eindhoven; 🇳🇱 Eindhoven, Netherlands

Andromed Rotterdam; 🇳🇱 Rotterdam, Netherlands

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Andromed Breda; 🇳🇱 Breda, Netherlands

Medicinkliniken; 🇸🇪 Stockholm, Sweden

Endokrinologkliniken; 🇸🇪 Malmo, Sweden

Andromed Oost; 🇳🇱 Velp, Netherlands

Andromed Zoetermeer; 🇳🇱 Zoetermeer, Netherlands

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Korea University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan

Chonnam National University Hospital; 🇰🇷 Kwangju, Korea, Republic of

Andromed Leiden; 🇳🇱 Leiden, Netherlands

St. Mary Hospital; 🇰🇷 Seoul, Korea, Republic of

Boehringer Ingelheim Investigational Site; 🇺🇦 Zaporozhye, Ukraine

Andromed Noord; 🇳🇱 Groningen, Netherlands

Gemini Ziekenhuis; 🇳🇱 Den Helder, Netherlands

Andromed Nijmegen; 🇳🇱 Nijmegen, Netherlands

Julius Center for Patient oriented Research; 🇳🇱 Utrecht, Netherlands

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of