Phase IV, 9 Weeks Comparison Between MICARDIS 80 mg and Amlodipine 10 mg on Biological PPAR Gamma Activities
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
1 other identifier
interventional
100
1 country
31
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 hypertension
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2005
CompletedFirst Posted
Study publicly available on registry
October 21, 2005
CompletedStudy Start
First participant enrolled
November 3, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2007
CompletedDecember 8, 2023
November 1, 2023
1.4 years
October 19, 2005
December 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of the serum adiponectin level at the end of study (6 weeks) between the two groups.
At week 6
Secondary Outcomes (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.
At week 6
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
502.486.3302A Cabinet Médical
Angers, France
502.486.3302B Cabinet Médical
Angers, France
502.486.3303A Boehringer Ingelheim Investigational Site
Angers, France
502.486.3305A Cabinet Médical
Angers, France
502.486.3323A Cabinet Médical
Angers, France
502.486.3323B Cabinet Médical
Angers, France
502.486.3324A Cabinet Médical
Angers, France
502.486.3324B Cabinet Médical
Angers, France
502.486.3325A Cabinet médical
Angers, France
502.486.3326A Cabinet Médical
Angers, France
502.486.3328A Cabinet Médical
Angers, France
502.486.3306A Cabinet Médical
Briollay, France
502.486.3307A Cabinet Médical
Chemillé-Melay, France
502.486.3319A Cabinet Médical
Cherbourg, France
502.486.3320A Cabinet Médical
Cherbourg, France
502.486.3320B Cabinet Médical
Cherbourg, France
502.486.3321A Cabinet Médical
Équeurdreville-Hainneville, France
502.486.3322A Boehringer Ingelheim Investigational Site
Évron, 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-Montlimart, France
502.486.3327A Cabinet Médical
Saumur, France
502.486.3309A Cabinet Médical Jean Charcot
Segré, France
502.486.3311A Cabinet Médical
Tiercé, France
502.486.3311B Cabinet Médical
Tiercé, France
502.486.3311C Cabinet Médical
Tiercé, France
502.486.3311D Cabinet Médical
Tiercé, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2005
First Posted
October 21, 2005
Study Start
November 3, 2005
Primary Completion
March 29, 2007
Last Updated
December 8, 2023
Record last verified: 2023-11