DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
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

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

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 With Metabolic Syndrome

Study design: Primary Purpose: Treatment

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:

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

Locations and Contacts

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, Chemille, 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, 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

502.486.3311A Cabinet Médical, Tierce, France

502.486.3311B Cabinet Médical, Tierce, France

502.486.3311C Cabinet Médical, Tierce, France

502.486.3311D Cabinet Médical, Tierce, France

Additional Information

Starting date: October 2005
Last updated: May 18, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017