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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00316095
Recruitment Status : Completed
First Posted : April 20, 2006
Last Update Posted : November 1, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE April 19, 2006
First Posted Date  ICMJE April 20, 2006
Last Update Posted Date November 1, 2013
Study Start Date  ICMJE April 2006
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2013)
  • Change in 24-hour ambulatory blood pressure measurement (ABPM) measured mean diastolic blood pressure (DBP) [ Time Frame: 8 weeks ]
  • Change in 24-hour ambulatory blood pressure measurement (ABPM) measured mean low density lipoprotein (LDL) [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2006)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2013)
  • Change in the 24-hour ABPM (Ambulatory Blood Pressure Monitoring) measured mean SBP [ Time Frame: after 8 weeks ]
  • Changes in Trough-to-peak ratios of SBP and DBP, taken from ABPM [ Time Frame: after 8 weeks ]
  • Changes in Seated morning DBP and SBP [ Time Frame: after 8 weeks ]
  • Response rate to blood pressure treatment [ Time Frame: after 8 weeks ]
  • Response rate to lipid lowering treatment [ Time Frame: after 8 weeks ]
  • Change in Total cholesterol [ Time Frame: after 8 weeks ]
  • Change in HDL-cholesterol [ Time Frame: after 8 weeks ]
  • Change in triglycerides [ Time Frame: after 8 weeks ]
  • Change in Apolipoprotein B [ Time Frame: after 8 weeks ]
  • Change in free fatty acids [ Time Frame: after 8 weeks ]
  • Change in Adiponectin [ Time Frame: after 8 weeks ]
  • Change in HOMA-index [ Time Frame: after 8 weeks ]
  • Change in haemoglobin A1C [ Time Frame: after 8 weeks ]
  • Changes in high sensitive c-reactive protein [ Time Frame: after 8 weeks ]
  • Changes in microalbuminuria [ Time Frame: after 8 weeks ]
  • Adverse events [ Time Frame: up to 15 weeks ]
  • Changes in clinical laboratory parameter [ Time Frame: up to 15 weeks ]
  • Assessment of pulse rate [ Time Frame: up to 15 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2006)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination of Telmisartan and Simvastatin in the Treatment of Hypertension and Hypercholesterolemia
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Dyslipidemias
Intervention  ICMJE
  • Drug: telmisartan
  • Drug: simvastatin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: December 19, 2007)
1695
Original Enrollment  ICMJE
 (submitted: April 19, 2006)
1500
Study Completion Date  ICMJE August 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   France,   Germany,   Hong Kong,   Korea, Republic of,   Netherlands,   Russian Federation,   Slovakia,   South Africa,   Sweden,   Taiwan,   Ukraine
Removed Location Countries China,   Hungary
 
Administrative Information
NCT Number  ICMJE NCT00316095
Other Study ID Numbers  ICMJE 1228.1
EudraCT No.: 2005-002851-41
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim BV/Alkmaar
PRS Account Boehringer Ingelheim
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP