Telmisartan 40 mg in Hypertension and Coronary Arteriosclerosis - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Methodology:

Randomised, double-blind and placebo-controlled parallel group design

Planned/actual number of subjects:

Enrolled: 40/50 randomised: 40/42 completed: 40/42

Diagnosis and main criteria for inclusion:

Treated essential hypertension with a mean seated DBP/SBP smaller than 95 mmHg/160 mmHg, coronary artery disease confirmed by catheterization and age equal or greater than 18 years of age.

Duration of treatment:

12 weeks: telmisartan 40 mg or placebo 40 mg

Study Hypothesis:

The statistical null hypothesis is that in patients with CAD and mild-to-moderate hypertension, a 84-day therapy with 40 mg telmisartan causes changes in inflammatory and leukocyte adhesion parameters. The alternative hypothesis is that this therapy does not influence inflammatory and leukocyte adhesion parameters. This hypothesis is tested by the nonparametric Wilcoxon test for unpaired samples.

Comparison(s):

Placebo 40 mg

Study Type

Interventional

Enrollment

42

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Homburg/Saar, Germany, 66421
    - Universitätsklinik des Saarlandes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Treated essential hypertension with a mean seated DBP < 95 mm Hg and a mean seated SBP < 160 mm Hg at the randomisation visit (baseline)
Coronary artery disease confirmed by cardiac catheterization
> 18 years of age
Ability to stop current antihypertensive therapy with ACE inhibitors, angioten-sin II receptor antagonist or lipid lowering therapy with statins without risk to the patient in the run-in period of two to four weeks and during the study period.
Ability to provide written informed consent.

Exclusion Criteria:

Acute coronary syndromes.
Acute or chronic heart failure (left ventricular ejection fraction < 45 %).
Symptomatic valvular heart disease.
Inflammatory diseases (e.g., acute infection, rheumatic diseases, collagenosis).
Pre-menopausal women (last menstruation < 1 year prior to start of run-in period) who:
- Are not surgically sterile.
- Are nursing.
- Are of child-bearing potential and are NOT practicing acceptable means of birth control, do NOT plan to continue using this method throughout the study and do NOT agree to submit to periodic pregnancy testing during participation in studies of > 3-months duration. Acceptable methods of birth control include oral, implantable or injectable contraceptives.
Known or suspected secondary hypertension.
Mean sitting SBP > 160 mm Hg or mean sitting DBP > 95 mm Hg during any visit.
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- SGPT(ALT) or SGOT(AST) > than 2 times the upper limit of normal range .
- Serum creatinine > 2.3 mg/dL.
Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one kidney.
Clinically relevant hypokalaemia or hyperkalaemia.
Uncorrected volume depletion.
Uncorrected sodium depletion.
Primary aldosteronism.
Hereditary fructose intolerance.
Biliary obstructive disorders.
Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.
History of drug or alcohol dependency within 6 months.
Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol (cf. 4.2.1).
Current participation in another trial, or participation in a trial within a period of one month.
Known hypersensitivity to any component of the formulation.
Has no contra-indication to a placebo run-in period (e.g., recent stroke or MI).
Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of telmisartan.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Alterations in the inflammatory parameters: hsCRP, IL-6, IL-10, sICAM-1, TNF-alpha, MCP-1, LFA, MAC-1, L- selectin, FcyRIII and PECAM-1

Secondary Outcome Measures

Outcome Measure
Alterations of clinical parameters such as clinical outcome, and changes in blood pressure. Safety and tolerability in terms of incidence and severity of adverse events, changes in physical examination, heart rate, laboratory parameters, and 12-lead-ECG.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (Actual)

March 1, 2004

Study Completion

May 1, 2004

Study Registration Dates

First Submitted

January 9, 2006

First Submitted That Met QC Criteria