Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients - Full Text View

Sponsor:	Ludwig-Maximilians - University of Munich
Collaborator:	Bayer
Information provided by:	Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:	NCT00560430

Purpose

A number of studies have shown that certain blood-pressure medications such as ACE-inhibitors and angiotensin-II-receptor blockers (ARB) can reduce the incidence of diabetes mellitus type 2. This protocol will evaluate whether inflammatory mechanisms mediate this effect. The investigators therefore will investigate the effect of telmisartan, a potent ARB, on lipid metabolism, glucose metabolism and inflammation in patients with the metabolic syndrome. Specific parameters will be tested before treatment and after 3 months of treatment. Placebo will be compared to 2 different doses of telmisartan per day.

Condition	Intervention	Phase
Hypertension Metabolic Syndrome Hypertriglyceridemia	Drug: telmisartan Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Metabolic Syndrome Triglycerides

Drug Information available for: Telmisartan

U.S. FDA Resources

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:

change in IL-6 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

change in fasting lipids; [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
change in postprandial lipid metabolism [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
change in inflammatory parameters [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
change in glucose metabolism [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Enrollment:	56
Study Start Date:	November 2007
Study Completion Date:	October 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: T1 Telmisartan 80 mg/d	Drug: telmisartan 80 mg per day, orally, weeks 1-14
Active Comparator: T2 Telmisartan 160 mg/d	Drug: telmisartan 80 mg per day; orally, weeks 1 and 2; 160 mg per day; orally, weeks 3-14
Placebo Comparator: P placebo	Drug: placebo placebo; orally weeks 1-14

Eligibility

Ages Eligible for Study:	19 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Abd. obesity (BMI>25kg/m²) and waist circumference ≥95cm (men),≥80cm (women)
Blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic)
Triglycerides 150-400 mg/dl
Normal stress test
Normal carotid ultrasound
Normal fundoscopy

Exclusion Criteria:

Diabetes mellitus
Secondary cause for insulin resistance
LDL-cholesterol >190 mg/dl
Atherosclerotic disease
Blood pressure >160 mmHg (systolic) and/or >100 mmHg (diastolic)
Regular alcohol consumption (>30 g/day)
Contraindication against telmisartan
Antihypertensive medications
Lipid lowering therapy
Malignancy
Pregnancy or Lactation
Women without adequate contraception

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560430

Locations

Germany
Center for Cardiovascular Research, University Berlin
Berlin, Germany, 10115
Med. Dept. 2, University Munich
Munich, Germany, 81377

Sponsors and Collaborators

Ludwig-Maximilians - University of Munich

Bayer

Investigators

Principal Investigator:

Klaus G Parhofer, MD

Ludwig-Maximilians - University of Munich

More Information

No publications provided

Responsible Party:	Klaus Parhofer, Principal investigator, Ludwig-Maximilians - University of Munich, Med. Dept. 2,
ClinicalTrials.gov Identifier:	NCT00560430 History of Changes
Other Study ID Numbers:	KPUK0106, EudraCT 2006-003567-31
Study First Received:	November 16, 2007
Last Updated:	July 14, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Hypertension
Hypertriglyceridemia
Metabolic Syndrome X
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders

Telmisartan
Benzoates
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012