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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242814
• Other study ID #: 502.486
• Status: Completed
• Phase: Phase 4
• Start date: November 3, 2005

Study information

• Verified date: November 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. primary completion date: March 29, 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• Micardis

• Amlodipine

Procedure:
• Abdominal biopsy

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the serum adiponectin level at the end of study (6 weeks) between the two groups.		At week 6
Secondary	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