Status:
UNKNOWN
Telmisartan, Amlodipine and Flow Mediated Dilation
Lead Sponsor:
Johannes Gutenberg University Mainz
Conditions:
Hypertension
Eligibility:
All Genders
35+ years
Phase:
PHASE4
Brief Summary
To show superior effects of the combination Telmisartan and Amlodipine (T and A) vs Olmesartan and Hydrochlorothiazide (O and HCTZ) on endothelial dysfunction as measured by flow mediated dilation (FM...
Detailed Description
This is a Phase IV, randomised, double-blind, forced- titration, active controlled, mono-center study to primarily compare the effects on endothelial function of the combination of telmisartan and aml...
Eligibility Criteria
Inclusion
- Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation.
- Age 35 and older.
- Male and female, treated and treatment-naive patients with uncontrolled hypertension (defined as 20/10 mmHg above target BP of \<140/90 mmHg \[\<130/80 mmHg for renally impaired and/ or diabetics patients\])
- Male and female treated patients with controlled hypertension (defined as target BP \< 140/90 mmHg \[ \< 130/80 mmHg for renally impaired and/ or diabetics patients\])
- \> 3 cardiovascular risk factors CVRFs and/or metabolic syndrome and/or diabetes mellitus and/or end organ damage
Exclusion
- Pretreatment with Telmisartan within the last 3 months.
- Pretreatment with Amlodipine, Diuretics and AT1Blocker/ACEInhibitor within the last 3 months
- Myocardial infarction within last 6 months.
- Previous stroke or hemodynamically relevant stenosis of carotic arteria (\>70%).
- Previous cardial or peripheral bypass surgery within last 6 months.
- PAD stadium III - IV n.F.
- Chronic heart failure NYHA III- IV.
- Unstable angina.
- Known intolerance to angiotensin receptor blockers, diuretics or dihydropyridine calcium channel blocker.
- Pre-menopausal women (last menstruation ≤1 year prior to signing informed consent) who:
- are not surgically sterile; or
- are nursing, or
- are pregnant, or
- are of childbearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the trial.
- The only acceptable methods of birth control are:
- Intra-Uterine Device (IUD)
- Oral
- implantable or injectable contraceptives
- Estrogen patch
- Hormonal birth control should have been in use for at least three months before the study and continue at least until the next menstrual period after completing the study
- Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
- Known or suspected secondary hypertension (e.g., renal artery stenosis or phaeochromocytoma)
- Mean in-clinic seated cuff SBP ≥180 mmHg and/or DBP ≥110 mmHg
- Renal dysfunction as defined by the following laboratory parameters:
- Serum creatinine \>3.0 mg/dL (or \>265 μmol/L) and/or known estimated creatinine clearance of \<30 ml/min and/or clinical markers of severe renal impairment.
- Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney
- Clinically relevant hypokalemia or hyperkalemia (i.e., \<3.0 or \>5.5 mEq/L, may be rechecked for suspected error in result)
- Uncorrected sodium or volume depletion
- Primary aldosteronism
- Hereditary fructose intolerance
- Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency
- Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator
- Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
- Patients whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C ≥10%
- Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists
- History of drug or alcohol abuses within six months prior to signing the informed consent form
- Concomitant administration of any medications known to affect BP, except medications allowed by the protocol
- Any investigational drug therapy within one month of signing the informed consent
- Known contraindication to any component of the trial drugs (telmisartan, amlodipine, olmesartan, hydrochlorothiazide)
- History of non-compliance or inability to comply with prescribed medications or protocol procedures
- 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 medication
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2011
Estimated Enrollment :
576 Patients enrolled
Trial Details
Trial ID
NCT01180205
Start Date
August 1 2010
End Date
October 1 2011
Last Update
July 12 2011
Active Locations (1)
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1
Universitätsmedizin Mainz
Mainz, Rhineland-Palatinate, Germany, 55131