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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00242814
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : May 21, 2012
Sponsor:
Information provided by:
Boehringer Ingelheim

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. 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 or disease Intervention/treatment Phase
Hypertension Metabolic Syndrome X Drug: Micardis Drug: Amlodipine Procedure: Abdominal biopsy Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
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
Study Start Date : October 2005
Actual Primary Completion Date : March 2007





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

Secondary Outcome Measures :
  1. 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00242814


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00242814    
Other Study ID Numbers: 502.486
First Posted: October 21, 2005    Key Record Dates
Last Update Posted: May 21, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Amlodipine
Telmisartan
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists