Regulation of Inflammatory Parameters by Telmisartan in H... | NCT00560430

Studies
Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients

NCT00560430

Sponsor

Ludwig-Maximilians - University of Munich

Status

Completed

Last Update Posted

Jul 15, 2010Estimated

Enrollment

56Actual

Phase

Phase 3

Conditions

Hypertension
Metabolic Syndrome
Hypertriglyceridemia

Interventions

telmisartan
telmisartan
placebo

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT 2006-003567-31

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Sep 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Nov 16, 2007

First Submission Date that Met QC Criteria

Nov 16, 2007

First Posted Date

Nov 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2010

Last Update Posted Date

Jul 15, 2010Estimated

Name	Class
Bayer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
T1	Active Comparator	Telmisartan 80 mg/d	Drug: telmisartan
T2	Active Comparator	Telmisartan 160 mg/d	Drug: telmisartan
P	Placebo Comparator	placebo	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
telmisartan	Drug	80 mg per day, orally, weeks 1-14	T1
telmisartan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in IL-6		14 weeks

Secondary Outcomes

Measure	Description	Time Frame
change in fasting lipids;		14 weeks
change in postprandial lipid metabolism		14 weeks
change in inflammatory parameters

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Klaus G Parhofer, MD	Ludwig-Maximilians - University of Munich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Cardiovascular Research, University Berlin		Berlin		10115	Germany
Med. Dept. 2, University Munich

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D024821	Metabolic Syndrome
D015228	Hypertriglyceridemia

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D007333	Insulin Resistance
D006946	Hyperinsulinism

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077333	Telmisartan

Ancestor Terms

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided