Status:
COMPLETED
Phase IV, 9 Weeks Comparison Between MICARDIS 80 mg and Amlodipine 10 mg on Biological PPAR Gamma Activities
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hypertension
Metabolic Syndrome X
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
The objective of the study is to compare PPAR activities (increase of adiponectin level) between MICARDIS and amlodipine after 6 weeks of treatment in hypertensive patients with metabolic syndrome. Mo...
Eligibility Criteria
Inclusion
- Patient written informed consent is signed prior to any trial specific procedures participation
- male patients \> 18 years
- Mean seated SBP \> 130mmHg and/or DBP \> 85mmHg treated with antihypertensive drug(s)
- with at least 2 more criteria of metabolic syndrome (NCEPT III). Biological data available within 6 months prior to enrollment visit.
- abdominal obesity \> 102 cm at screening
- TG \> 1.5 g/l
- HDL \< 0.4 g/l
- Glycemia \> 6 mmol/l
Exclusion
- Patients with any of the following conditions will be excluded from trial:
- confirmed type 1 or 2 diabetic patients treated or not
- secondary hypertension
- Mean seated SBP\>180 mmHg and/or DBP \>110 mmHg at screening
- hepatic and/or renal dysfunction as defined by the following laboratory parameters at visit 1:
- SGPT (ALT) or SGOT (AST) ¿ twice the upper limit of the normal range
- serum creatinine ¿ 2.3 mg/dL (or 203 ¿mol/L)
- bilateral renal artery stenosis or renal artery stenosis in a solitary kidney
- patients post-renal transplant or with only one functioning kidney
- clinically relevant hypokalemia or hyperkalemia at visit 1
- uncorrected volume or sodium depletion at visit 1
- primary aldosteronism
- hereditary or known fructose intolerance
- biliary obstructive disorders
- patients who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin-II receptor antagonists
- history of drug or alcohol dependency within the previous six months
- concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form
- symptomatic congestive heart failure (New York Heart Academy (NYHA) functional class CHF II-IV)
- unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery less than three months prior to informed consent
- stroke less than six months prior to informed consent
- sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant arrhythmias as determined by the investigator
- hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
- known allergic hypersensitivity to any component of the formulations under investigation
- concomitant therapy with lithium, cholestyramine or colestipol resins continued after visit 1
Key Trial Info
Start Date :
November 3 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00242814
Start Date
November 3 2005
Last Update
December 8 2023
Active Locations (31)
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1
502.486.3302A Cabinet Médical
Angers, France
2
502.486.3302B Cabinet Médical
Angers, France
3
502.486.3303A Boehringer Ingelheim Investigational Site
Angers, France
4
502.486.3305A Cabinet Médical
Angers, France