TELMA - Observational Study in Daily Medical Practice of the Effectiveness of Telmisartan for Treatment of Hypertension in Patients With and Without Confirmed Albuminuria in Belgium - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00886288

Purpose

This study was carried out in the context of daily medical practice to compare the effectiveness of telmisartan in the treatment of hypertension complicated or not with the presence of protein in the urine, which is called albuminuria. Hypertension is a chronic, treatable but not curable disease and is defined as a combination of a systolic blood pressure of 140 mmHg or more and a diastolic pressure of 90 mmHg or more. The kidneys are often the first organs damaged by hypertension; renal damage could easily be diagnosed using a urine dipstick and should be part of a routine examination in hypertensive patient. The aim of the study is to see if the decrease of blood pressure (both systolic and diastolic) after approximately 12 weeks of treatment with telmisartan in patients with albuminuria is the same or different to that in patients without albuminuria. Every patient participating should have two visits, approximately 12 weeks apart where his/her blood pressure was checked and a few questions about is concomitant disease and drugs were asked.

Condition
Hypertension

MedlinePlus related topics: High Blood Pressure Urine and Urination

Drug Information available for: Telmisartan

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	A Comparison of Telmisartan Effectiveness in Hypertensive Patients With and Without Albuminuria

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

The % of patients whose blood pressure is under control with telmisartan after approximately 12 weeks. Control SBP/DBP < 140 mmHg/90 mmHg or SBP/DBP < 130/80 mmHg if the patient has diabetes or chronic renal insufficiency [ Time Frame: 12 weeks ]

Secondary Outcome Measures:

Absolute difference between SBP and DBP measurements at baseline and after 12 weeks [ Time Frame: 12 weeks ]
Percentage of responders (decrease in SBP > or = 10 mmHg) [ Time Frame: 12 weeks ]
Evolution of albuminuria/renal function [ Time Frame: 12 weeks ]
Safety (any adverse events reported during the study) [ Time Frame: 12 weeks ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	3010
Study Start Date:	September 2006
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age > or = 18, no upper limit
Patient has been treated and followed up for more than 6 months by the same GP
Hypertension treated for at least 3 months and not under control at the time of inclusion in the study
Results available from at least two tests of albuminuria
Antihypertensive treatment remained unchanged during the month prior data collection
Decision by the GP to introduce telmisartan (either in combination with HCTZ or not) in the antihypertensive treatment (normal prescription)
Written informed consent of the patient to collect his/her data

Exclusion Criteria:

Blood pressure under control
The patient refuse to allow his/her data to be collected
Women of child-bearing potential not using an effective contraception method, as well as women who are breastfeeding
Patients with proteinuria of > or = 1g/l or GFR < 15 ml/min/1.73 m²
Current or prior use of telmisartan within the last 12 months
Change in the antihypertensive treatment during the month prior to collection of the data

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886288

Show 935 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	502.521
Study First Received:	April 21, 2009
Last Updated:	April 21, 2009
ClinicalTrials.gov Identifier:	NCT00886288 History of Changes
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Study placed in the following topic categories:

Angiotensin II Type 1 Receptor Blockers
Signs and Symptoms
Proteinuria
Albuminuria
Urologic Diseases
Urination Disorders

Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Telmisartan
Angiotensin II
Protease Inhibitors
Hypertension

Additional relevant MeSH terms:

Albuminuria
Molecular Mechanisms of Pharmacological Action
Urination Disorders
Vascular Diseases
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers

Urological Manifestations
Signs and Symptoms
Proteinuria
Urologic Diseases
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Telmisartan
Hypertension

ClinicalTrials.gov processed this record on May 06, 2009