Phase IV, 9 Weeks Comparison Between MICARDIS 80 mg and Amlodipine 10 mg on Biological PPAR Gamma Activities
Information source: Boehringer Ingelheim Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Metabolic Syndrome X
Intervention: Micardis (Drug); Amlodipine (Drug); Abdominal biopsy (Procedure)
Phase: Phase 4
Status: Completed
Sponsored by: Boehringer Ingelheim Pharmaceuticals Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals
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. Moreover, this study will compare serum level of inflammatory markers of
the metabolic syndrome after 6 weeks of treatment.
An ancillary study performed in one center will assess adipocyte differentiation (PPAR gamma
stimulation) in 30 subjects (15 per arm).
Clinical Details
Official title: A Phase IV Study, Prospective, Randomised, Open Label, Blinded Endpoint, Parallel Group, 9 Weeks of Comparison Between Oral Administration of Telmisartan Tablet (80mg Once Daily) and Amlodipine Tablet (10 mg Once Daily) on Biological PPAR Gamma Activities in Non Controlled Hypertensive Male Patients
Study design: N/A
Primary outcome: Comparison of the serum adiponectin level at the end of study (6 weeks) between the two groups.
Secondary outcome: Comparison of serum level of TNF alpha, IL-6, leptine, hsCRP, TG, HDL and blood pressure control between two groups. Adipocyte differentiation in 30 patients (PPAR gamma stimulation) between two groups.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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
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
Locations and Contacts
Boehringer Ingelheim Investigational Site, Angers, France
Boehringer Ingelheim Investigational Site, Briollay, France
Boehringer Ingelheim Investigational Site, Chemille, France
Boehringer Ingelheim Investigational Site, Montrevault, France
Boehringer Ingelheim Investigational Site, Segre, France
Boehringer Ingelheim Investigational Site, Saint Pierre Montlimard, France
Boehringer Ingelheim Investigational Site, Tierce, France
Boehringer Ingelheim Investigational Site, Feneu, France
Boehringer Ingelheim Investigational Site, La Rochelle, France
Boehringer Ingelheim Investigational Site, Nieul sur Mer, France
Boehringer Ingelheim Investigational Site, Cherbourg, France
Boehringer Ingelheim Investigational Site, Equeurdreville, France
Boehringer Ingelheim Investigational Site, Evron, France
Hopital Pitie Salpetriere, Paris, France
Boehringer Ingelheim Investigational Site, Saumur, France
Additional Information
Ending date: January 2008
Last updated: June 5, 2008
|
