hypertension and dyslipidaemia
Conditions
Interventions
Product Name: Micardis 80 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: telmisartan
Current Sponsor code: BIBR 277
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration num
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patients with all of the following inclusion criteria will be considered for randomization: 1.) Willing and able to provide written informed consent 2.) Age 18 years or older 3.) Hypertension as defined by a mean seated cuff DBP of ? 95 – 109 mmHg at visit 3.1 4.) Hypercholesterolemia as defined by a fasting LDL-C level at visit 2 according to CV risk shown in table below: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.) pre-menopausal women (last menstruation = 1 year prior to informed consent) 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, do not plan to continue using this method throughout the trial and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable means of birth control include the transdermal patch, oral, implantable or injectable contraceptives, Intra Uterine Devices (IUDs), sexual abstinence and vasectomised partner. No exceptions will be made. 2.) inability to stop current antihypertensive and/or cholesterol-lowering therapies for reason of unacceptable risk to the patient (Investigator’s discretion) 3.) contra-indication to a washout/placebo treatment (e.g. stroke or transient ischemic attacks within the past six months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months of signing the informed consent form) 4.) clinically relevant cardiac arrhytmias (e.g. ventricular tachycardia, atrial fibrillation, atrial flutter) as determined by the investigator 5.) hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve 6.) mean sitting SBP ? 180 mmHg or mean sitting DBP ? 110 mmHg during washout and run-in at two consecutive visits (up to and including visit 3.2) 7.) known or suspected secondary hypertension (e.g., primary aldosteronism) 8.) known or suspected secondary hyperlipidemia of any etiology, such as nephrotic syndrome, hypothyroidism, dysproteinemia, obstructive liver disease, or Cushing’s syndrome 9.) diabetes that has not been stable and controlled (HbA1C ? 10%) for the previous three months 10.) severe renal dysfunction as defined by serum creatinine > 3.0 mg/dL (>265 µmol/L) or creatinine clearance 2 times upper limit of normal range) of SGOT (AST) or SGPT (ALT) 13.) clinically relevant hypokalaemia or hyperkalaemia 14.) uncorrected volume depletion 15.) uncorrected sodium depletion 16.) any history of myopathy or rhabdomyolysis during the past treatment with HMG Co-A reductase inhibitors 17.) concurrent use of large quantities of grapefruit juice (> 1L each day) and drugs know to increase simvastatin concentrations and consequently the risk of myopathy / rhabdomyolysis (see drug restriction list) 18.) known hypersensitivity or intolerance to HMG Co-A reductase inhibitors and/or angiotensin receptor blockers, or to any of the components within the trial medications; patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists 19.) hereditary fructose intolerance 20.) planned significant diet and/or lifestyle (including exercise) changes during the treatment phase of the trial 21.) history of drug or alcohol dependency within six months prior to signing the informed consent or ongoing excessive alcohol consumption (>21 drinks each week) 22.) any investigational drug therapy within one month of providing informed consent 23.) any other clinical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The first primary objective of this trial is to demonstrate that combinations of telmisartan (T20 mg and T80 mg) and simvastatin (S20 mg and S40 mg) have similar efficacy in reducing 24 hour mean DBP compared to the respective telmisartan monotherapy, and have similar efficacy in reducing LDL cholesterol compared to the respective simvastatin monotherapy. This will be shown by confirming that the combinations are non inferior in the reduction of mean DBP compared to telmisartan alone, and in the reduction of LDL cholesterol compared to simvastatin alone, in patients with hypertension and hypercholesterolemia. ;Secondary Objective: The secondary aim of this trial is to demonstrate that combinations of telmisartan (T20 mg and T80 mg) with simvastatin (S20 mg and S40 mg) are superior in the reduction of mean DBP compared to simvastatin alone, and in the reduction of LDL cholesterol compared to telmisartan alone, in patients with hypertension and hypercholesterolemia. ;Primary end point(s): The primary endpoint is the change from baseline to the end of trial (8 weeks) of 24-hour ABPM measured mean DBP and LDL-cholesterol levels in the combination groups as compared to the single (active) component groups: • absolute change from baseline to the end of trial of 24-hour mean DBP for low dose telmisartan combined with high dose simvastatin (T20/S40) as compared to low dose telmisartan (T20) • absolute change from baseline to the end of trial of 24-hour mean DBP for high dose telmisartan combined with high dose simvastatin (T80/S40) as compared to high dose telmisartan (T80) • percent change from baseline to the end of trial of LDL cholesterol for high dose telmisartan combined with low dose simvastatin (T80/S20) as compared to low dose simvastatin (S20) • percent change from baseline to the end of trial of LDL cholesterol for high dose telmisartan combined with high dose simvastatin (T80/S40) as compared to high dose simvastatin (S40) The second primary | — |
Countries
Czech Republic, Germany, Sweden
Outcome results
None listed