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

Primary Purpose

Hypertension, Metabolic Syndrome X

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Micardis
Amlodipine
Abdominal biopsy
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • 502.486.3302A Cabinet Médical
  • 502.486.3302B Cabinet Médical
  • 502.486.3303A Boehringer Ingelheim Investigational Site
  • 502.486.3305A Cabinet Médical
  • 502.486.3323A Cabinet Médical
  • 502.486.3323B Cabinet Médical
  • 502.486.3324A Cabinet Médical
  • 502.486.3324B Cabinet Médical
  • 502.486.3325A Cabinet médical
  • 502.486.3326A Cabinet Médical
  • 502.486.3328A Cabinet Médical
  • 502.486.3306A Cabinet Médical
  • 502.486.3307A Cabinet Médical
  • 502.486.3319A Cabinet Médical
  • 502.486.3320A Cabinet Médical
  • 502.486.3320B Cabinet Médical
  • 502.486.3321A Cabinet Médical
  • 502.486.3322A Boehringer Ingelheim Investigational Site
  • 502.486.3312A Cabinet Médical
  • 502.486.3315A Cabinet Médical
  • 502.486.3308A Cabinet Médical
  • 502.486.3316A Boehringer Ingelheim Investigational Site
  • 502.486 3301A Boehringer Ingelheim Investigational Site
  • 502.486.3301B Hôpital Pitié Salpêtrière
  • 502.486.3310A Cabinet Médical
  • 502.486.3327A Cabinet Médical
  • 502.486.3309A Cabinet Médical Jean Charcot
  • 502.486.3311A Cabinet Médical
  • 502.486.3311B Cabinet Médical
  • 502.486.3311C Cabinet Médical
  • 502.486.3311D Cabinet Médical

Outcomes

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.

Full Information

First Posted
October 19, 2005
Last Updated
May 18, 2012
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00242814
Brief Title
Phase IV, 9 Weeks Comparison Between MICARDIS 80 mg and Amlodipine 10 mg on Biological PPAR Gamma Activities
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 Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Metabolic Syndrome X

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Micardis
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Intervention Type
Procedure
Intervention Name(s)
Abdominal biopsy
Primary Outcome Measure Information:
Title
Comparison of the serum adiponectin level at the end of study (6 weeks) between the two groups.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
502.486.3302A Cabinet Médical
City
Angers
Country
France
Facility Name
502.486.3302B Cabinet Médical
City
Angers
Country
France
Facility Name
502.486.3303A Boehringer Ingelheim Investigational Site
City
Angers
Country
France
Facility Name
502.486.3305A Cabinet Médical
City
Angers
Country
France
Facility Name
502.486.3323A Cabinet Médical
City
Angers
Country
France
Facility Name
502.486.3323B Cabinet Médical
City
Angers
Country
France
Facility Name
502.486.3324A Cabinet Médical
City
Angers
Country
France
Facility Name
502.486.3324B Cabinet Médical
City
Angers
Country
France
Facility Name
502.486.3325A Cabinet médical
City
Angers
Country
France
Facility Name
502.486.3326A Cabinet Médical
City
Angers
Country
France
Facility Name
502.486.3328A Cabinet Médical
City
Angers
Country
France
Facility Name
502.486.3306A Cabinet Médical
City
Briollay
Country
France
Facility Name
502.486.3307A Cabinet Médical
City
Chemille
Country
France
Facility Name
502.486.3319A Cabinet Médical
City
Cherbourg
Country
France
Facility Name
502.486.3320A Cabinet Médical
City
Cherbourg
Country
France
Facility Name
502.486.3320B Cabinet Médical
City
Cherbourg
Country
France
Facility Name
502.486.3321A Cabinet Médical
City
Equeurdreville
Country
France
Facility Name
502.486.3322A Boehringer Ingelheim Investigational Site
City
Evron
Country
France
Facility Name
502.486.3312A Cabinet Médical
City
Feneu
Country
France
Facility Name
502.486.3315A Cabinet Médical
City
La Rochelle
Country
France
Facility Name
502.486.3308A Cabinet Médical
City
Montrevault
Country
France
Facility Name
502.486.3316A Boehringer Ingelheim Investigational Site
City
Nieul sur Mer
Country
France
Facility Name
502.486 3301A Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
502.486.3301B Hôpital Pitié Salpêtrière
City
Paris
Country
France
Facility Name
502.486.3310A Cabinet Médical
City
Saint Pierre Montlimard
Country
France
Facility Name
502.486.3327A Cabinet Médical
City
Saumur
Country
France
Facility Name
502.486.3309A Cabinet Médical Jean Charcot
City
Segre
Country
France
Facility Name
502.486.3311A Cabinet Médical
City
Tierce
Country
France
Facility Name
502.486.3311B Cabinet Médical
City
Tierce
Country
France
Facility Name
502.486.3311C Cabinet Médical
City
Tierce
Country
France
Facility Name
502.486.3311D Cabinet Médical
City
Tierce
Country
France

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.486.pdf
Description
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Phase IV, 9 Weeks Comparison Between MICARDIS 80 mg and Amlodipine 10 mg on Biological PPAR Gamma Activities

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