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.

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 2000

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

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 < 0.6 ml/sec

11.)bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one kidney

12.)biliary obstructive disorders, hepatic insufficiency, including past or current liver disease or unexplained elevations (>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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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