Phase IV, 9 Weeks Comparison Between MICARDIS 80 mg and Amlodipine 10 mg on Biological PPAR Gamma Activities

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00242814
First received: October 19, 2005
Last updated: May 18, 2012
Last verified: May 2012
  Purpose

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).


Condition Intervention Phase
Hypertension
Metabolic Syndrome X
Drug: Micardis
Drug: Amlodipine
Procedure: Abdominal biopsy
Phase 4

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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 With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Comparison of the serum adiponectin level at the end of study (6 weeks) between the two groups.

Secondary Outcome Measures:
  • 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.

Enrollment: 100
Study Start Date: October 2005
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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

Exclusion Criteria:

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242814

Locations
France
502.486.3305A Cabinet Médical
Angers, France
502.486.3324A Cabinet Médical
Angers, France
502.486.3303A Boehringer Ingelheim Investigational Site
Angers, France
502.486.3324B Cabinet Médical
Angers, France
502.486.3326A Cabinet Médical
Angers, France
502.486.3325A Cabinet médical
Angers, France
502.486.3328A Cabinet Médical
Angers, France
502.486.3323A Cabinet Médical
Angers, France
502.486.3302A Cabinet Médical
Angers, France
502.486.3323B Cabinet Médical
Angers, France
502.486.3302B Cabinet Médical
Angers, France
502.486.3306A Cabinet Médical
Briollay, France
502.486.3307A Cabinet Médical
Chemille, France
502.486.3319A Cabinet Médical
Cherbourg, France
502.486.3320B Cabinet Médical
Cherbourg, France
502.486.3320A Cabinet Médical
Cherbourg, France
502.486.3321A Cabinet Médical
Equeurdreville, France
502.486.3322A Boehringer Ingelheim Investigational Site
Evron, France
502.486.3312A Cabinet Médical
Feneu, France
502.486.3315A Cabinet Médical
La Rochelle, France
502.486.3308A Cabinet Médical
Montrevault, France
502.486.3316A Boehringer Ingelheim Investigational Site
Nieul sur Mer, France
502.486 3301A Boehringer Ingelheim Investigational Site
Paris, France
502.486.3301B Hôpital Pitié Salpêtrière
Paris, France
502.486.3310A Cabinet Médical
Saint Pierre Montlimard, France
502.486.3327A Cabinet Médical
Saumur, France
502.486.3309A Cabinet Médical Jean Charcot
Segre, France
502.486.3311B Cabinet Médical
Tierce, France
502.486.3311D Cabinet Médical
Tierce, France
502.486.3311C Cabinet Médical
Tierce, France
502.486.3311A Cabinet Médical
Tierce, France
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00242814     History of Changes
Other Study ID Numbers: 502.486
Study First Received: October 19, 2005
Last Updated: May 18, 2012
Health Authority: France: AFSSAPS

Additional relevant MeSH terms:
Hypertension
Metabolic Syndrome X
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Amlodipine
Telmisartan
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014