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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00316095
First received: April 19, 2006
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Hypertension
Dyslipidemias
Drug: telmisartan
Drug: simvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change in 24-hour ambulatory blood pressure measurement (ABPM) measured mean diastolic blood pressure (DBP) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in 24-hour ambulatory blood pressure measurement (ABPM) measured mean low density lipoprotein (LDL) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in the 24-hour ABPM (Ambulatory Blood Pressure Monitoring) measured mean SBP [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Changes in Trough-to-peak ratios of SBP and DBP, taken from ABPM [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Changes in Seated morning DBP and SBP [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Response rate to blood pressure treatment [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Response rate to lipid lowering treatment [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Change in Total cholesterol [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Change in HDL-cholesterol [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Change in triglycerides [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Change in Apolipoprotein B [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Change in free fatty acids [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Change in Adiponectin [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Change in HOMA-index [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Change in haemoglobin A1C [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Changes in high sensitive c-reactive protein [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Changes in microalbuminuria [ Time Frame: after 8 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
  • Changes in clinical laboratory parameter [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
  • Assessment of pulse rate [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1695
Study Start Date: April 2006
Estimated Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316095

  Hide Study Locations
Locations
Czech Republic
Boehringer Ingelheim Investigational Site
Benatky nad Jizerou, Czech Republic, 294 71
Boehringer Ingelheim Investigational Site
Brno, Czech Republic, 65691
Boehringer Ingelheim Investigational Site
Mlada Boleslav, Czech Republic, 293 01
Boehringer Ingelheim Investigational Site
Plzen, Czech Republic, 301 00
Boehringer Ingelheim Investigational Site
Praha 5, Czech Republic, 158 00
Boehringer Ingelheim Investigational Site
Pribram, Czech Republic, 261 01
Boehringer Ingelheim Investigational Site
Unicov, Czech Republic, 783 91
Boehringer Ingelheim Investigational Site
Usti nad Orlici, Czech Republic, 562 18
France
Boehringer Ingelheim Investigational Site
Angers, France, 49000
ALTI
Angers, France, 49000
Boehringer Ingelheim Investigational Site
Sidi Daoud Tunis, France, 2046
Boehringer Ingelheim Investigational Site
Tunis, France, 1089
Germany
Boehringer Ingelheim Investigational Site
Haag, Germany, 83527
Boehringer Ingelheim Investigational Site
Mainz, Germany, 55116
Boehringer Ingelheim Investigational Site
Neuburg a. d. Donau, Germany, 86633
Boehringer Ingelheim Investigational Site
Nurnberg, Germany, 90402
Boehringer Ingelheim Investigational Site
Rednitzhembach, Germany, 91126
Boehringer Ingelheim Investigational Site
Unterschneidheim, Germany, 73485
Boehringer Ingelheim Investigational Site
Westerkappeln, Germany, 49492
Boehringer Ingelheim Investigational Site
Wiesbaden, Germany, 65191
Boehringer Ingelheim Investigational Site
Wurzburg, Germany, 97072
Hong Kong
Boehringer Ingelheim Investigational Site
Hong Kong, Hong Kong
Korea, Republic of
Chonnam National University Hospital
Kwangju, Korea, Republic of, 501757
Hallym University Sacred Heart Hospital
Kyunggi-do, Korea, Republic of, 431070
Severance Hospital
Seoul, Korea, Republic of, 120752
Korea University Medical Center
Seoul, Korea, Republic of, 136705
St. Mary Hospital
Seoul, Korea, Republic of, 150713
Seoul National University Hospital
Seoul, Korea, Republic of, 110774
Netherlands
Boehringer Ingelheim Investigational Site
Almere, Netherlands, 1311RL
Boehringer Ingelheim Investigational Site
Beek en Donk, Netherlands, 5741 CG
Andromed Breda
Breda, Netherlands, 4811 VL
Gemini Ziekenhuis
Den Helder, Netherlands, 1782 GZ
Andromed Eindhoven
Eindhoven, Netherlands, 5611 NJ
Boehringer Ingelheim Investigational Site
Ewijk, Netherlands, 6644 CL
Andromed Noord
Groningen, Netherlands, 9711 SG
Andromed Leiden
Leiden, Netherlands, 2311 GZ
Andromed Nijmegen
Nijmegen, Netherlands, 6533 HL
Boehringer Ingelheim Investigational Site
Oude Pekela, Netherlands, 9665 BJ
Andromed Rotterdam
Rotterdam, Netherlands, 3021 HC
Julius Center for Patient oriented Research
Utrecht, Netherlands, 3584 CJ
Andromed Oost
Velp, Netherlands, 6883 ES
Boehringer Ingelheim Investigational Site
Wildervank, Netherlands, 9648 BE
Andromed Zoetermeer
Zoetermeer, Netherlands, 2724 EK
Russian Federation
Boehringer Ingelheim Investigational Site
Moscow, Russian Federation, 101990
Boehringer Ingelheim Investigational Site
Moscow, Russian Federation, 129010
Boehringer Ingelheim Investigational Site
Moscow, Russian Federation, 121552
Boehringer Ingelheim Investigational Site
Moscow, Russian Federation, 127018
Boehringer Ingelheim Investigational Site
Moscow, Russian Federation, 117036
Boehringer Ingelheim Investigational Site
Moscow, Russian Federation, 119992
Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
Boehringer Ingelheim Investigational Site
Moscow, Russian Federation, 121356
Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation, 195257
Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation, 198013
Slovakia
Boehringer Ingelheim Investigational Site
Bratislava, Slovakia, 82606
Boehringer Ingelheim Investigational Site
Kosice, Slovakia, 040 01
Boehringer Ingelheim Investigational Site
Kralovsky Chmlec, Slovakia, 077 01
Boehringer Ingelheim Investigational Site
Liptovsky Hradok, Slovakia, 033 01
Boehringer Ingelheim Investigational Site
Nitra, Slovakia, 950 01
Boehringer Ingelheim Investigational Site
Povazska Bystrica, Slovakia, 017 01
Boehringer Ingelheim Investigational Site
Presov, Slovakia, 081 81
Boehringer Ingelheim Investigational Site
Trencin, Slovakia, 911 05
Boehringer Ingelheim Investigational Site
Vrable, Slovakia, 952 01
South Africa
Boehringer Ingelheim Investigational Site
Boksburg, South Africa, 1461
Boehringer Ingelheim Investigational Site
Cape Town, South Africa, 7405
Boehringer Ingelheim Investigational Site
Cape Town, South Africa, 7925
Boehringer Ingelheim Investigational Site
Durban, South Africa, 4091
Boehringer Ingelheim Investigational Site
Johannesburg, South Africa, 2033
Boehringer Ingelheim Investigational Site
Krugersdorp, South Africa, 1739
Boehringer Ingelheim Investigational Site
Midrand, South Africa, 1685
Sweden
Medicinkliniken
Goteborg, Sweden, 416 85
Boehringer Ingelheim Investigational Site
Lule?, Sweden, S-971 31
Medicinkliniken
Lule?, Sweden, 971 80
Endokrinologkliniken
Malmo, Sweden, 205 02
Boehringer Ingelheim Investigational Site
Rattvik, Sweden, 795 33
Medicinkliniken
Stockholm, Sweden, 182 88
Boehringer Ingelheim Investigational Site
Uppsala, Sweden, S-752 23
Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Mackay Memorial Hospital
Taipei, Taiwan, 104
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Ukraine
Boehringer Ingelheim Investigational Site
Dnepropetrovsk, Ukraine, 49023
Boehringer Ingelheim Investigational Site
Dnepropetrovsk, Ukraine, 49006
Boehringer Ingelheim Investigational Site
Ivano-Frankovsk, Ukraine, 76000
Boehringer Ingelheim Investigational Site
Kharkov, Ukraine, 61037
Boehringer Ingelheim Investigational Site
Kharkov, Ukraine, 61018
Boehringer Ingelheim Investigational Site
Kiev, Ukraine, 03680
Boehringer Ingelheim Investigational Site
Kiev, Ukraine, 03151
Boehringer Ingelheim Investigational Site
Kiev, Ukraine, 04114
Boehringer Ingelheim Investigational Site
Kiev, Ukraine, 02175
Boehringer Ingelheim Investigational Site
Lutsk, Ukraine, 43024
Boehringer Ingelheim Investigational Site
Lvov, Ukraine, 73013
Boehringer Ingelheim Investigational Site
Lvov, Ukraine, 79015
Boehringer Ingelheim Investigational Site
Zaporozhye, Ukraine, 69035
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim BV/Alkmaar
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00316095     History of Changes
Other Study ID Numbers: 1228.1, EudraCT No.: 2005-002851-41
Study First Received: April 19, 2006
Last Updated: October 31, 2013
Health Authority: Netherlands: Commissie Mensgebonden Onderzoek (CCMO)
Austria: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Austria: Ministry of Health Crae of Ukraine (MoH of Ukraine)
France: Agence Francaise de Securite Sanitaire des Produits de Sante
Sweden: Medical Products Agency
South Africa: Medicines Control Council (MCC)
Taiwan: Department of Health, Executive Yuan, ROC
Hong Kong: Department of Health Pharmaceuticals Registration and Import / Export Central Section
Germany: BfArM (Bundesagentur fuer Arzneimittel und Medizinalprodukte)
China: Food and Drug Administration
Korea, Republic of: Korea Food and Drug Administration
Austria: SUKL (state institute for drug control)
Austria: State Institute for Drug Control (SUKL)

Additional relevant MeSH terms:
Dyslipidemias
Hypertension
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Simvastatin
Telmisartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anticholesteremic Agents
Antihypertensive Agents
Antimetabolites
Cardiovascular Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014