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Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients (METATEL)

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00560430
First received: November 16, 2007
Last updated: July 14, 2010
Last verified: May 2008

November 16, 2007
July 14, 2010
November 2007
September 2009   (final data collection date for primary outcome measure)
change in IL-6 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
change in IL-6 [ Time Frame: 14 weeks ]
Complete list of historical versions of study NCT00560430 on ClinicalTrials.gov Archive Site
  • 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 ]
change in fasting lipids; change in postprandial lipids; change in inflammatory parameters; change in glucose metabolism; [ Time Frame: 14 weeks ]
Not Provided
Not Provided
 
Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients
Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Hypertension
  • Metabolic Syndrome
  • Hypertriglyceridemia
  • Drug: telmisartan
    80 mg per day, orally, weeks 1-14
  • Drug: telmisartan
    80 mg per day; orally, weeks 1 and 2; 160 mg per day; orally, weeks 3-14
  • Drug: placebo
    placebo; orally weeks 1-14
  • Active Comparator: T1
    Telmisartan 80 mg/d
    Intervention: Drug: telmisartan
  • Active Comparator: T2
    Telmisartan 160 mg/d
    Intervention: Drug: telmisartan
  • Placebo Comparator: P
    placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
October 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
19 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00560430
KPUK0106, EudraCT 2006-003567-31
No
Klaus Parhofer, Principal investigator, Ludwig-Maximilians - University of Munich, Med. Dept. 2,
Ludwig-Maximilians - University of Munich
Bayer
Principal Investigator: Klaus G Parhofer, MD Ludwig-Maximilians - University of Munich
Ludwig-Maximilians - University of Munich
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP