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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

Completed
Conditions
Hypertension
Registration Number
NCT00886288
Lead Sponsor
Boehringer Ingelheim
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
2874
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Percentage of Patients With Controlled Blood Pressureapproximately 12 weeks (10 to 14 weeks) after baseline

Systolic blood pressure (SBP) \< 140 mmHg and diastolic blood pressure (DBP) \< 90 mmHg if the patient has:

* no chronic renal insufficiency or macroalbuminuria-dipsticks negative,

* albuminuria is \< 300 mg/24h or \< 200 mg albumin per gram of creatinine

* no diabetes

or SBP \< 130 mmHg and DBP \< 80 mmHg if the patient has:

* chronic renal insufficiency or macroalbuminuria-dipsticks are positive, albuminuria ≥ 300 mg/24h or ≥ 200 mg albumin per gram of creatinine

* diabetes (type 1 or 2)

Secondary Outcome Measures
NameTimeMethod
Mean Difference in Systolic Blood Pressurebaseline and approximately 12 weeks

The fall in systolic blood pressure (SBP) after approximately 12 weeks of treatment including telmisartan defined as SBP (baseline) - SBP (12 weeks) expressed in mmHg

Mean Difference in Diastolic Blood Pressurebaseline and approximately 12 weeks

The fall in diastolic blood pressure (DBP) after approximately 12 weeks of treatment including telmisartan defined as DBP (baseline) - DBP (12 weeks) expressed in mmHg

Percentage of Patients With a Decrease of Systolic Blood Pressure (SBP) ≥ 10 mmHg (Responders)approximately 12 weeks (10 to 14 weeks) after baseline

The response in SBP after approximately 12 weeks of treatment including telmisartan defined as a fall in SBP (SBP (baseline) - SBP (12 weeks) ≥ 10 mmHg

Percentage of Patients Presenting an Adverse Event (AE)baseline to the end of study period

Percentage of patients with any adverse events during the study period, related or not to investigational drug

Percentage of Patients With Positive to Negative Shift in AlbuminuriaApproximately 12 weeks (10 to 14 weeks) after baseline

Percentage of patients shifting from with (positive) albuminuria at baseline to without (negative) albuminuria after approximately 12 weeks

Trial Locations

Locations (936)

Boehringer Ingelheim Investigational Site 1

🇧🇪

Aalst, Belgium

Boehringer Ingelheim Investigational Site 2

🇧🇪

Aalst, Belgium

Boehringer Ingelheim Investigational Site 3

🇧🇪

Aalst, Belgium

Boehringer Ingelheim Investigational Site 4

🇧🇪

Aalst, Belgium

Boehringer Ingelheim Investigational Site 5

🇧🇪

Aalter, Belgium

Boehringer Ingelheim Investigational Site 6

🇧🇪

Aalter, Belgium

Boehringer Ingelheim Investigational Site 10

🇧🇪

Aarschot, Belgium

Boehringer Ingelheim Investigational Site 11

🇧🇪

Aarschot, Belgium

Boehringer Ingelheim Investigational Site 7

🇧🇪

Aarschot, Belgium

Boehringer Ingelheim Investigational Site 8

🇧🇪

Aarschot, Belgium

Scroll for more (926 remaining)
Boehringer Ingelheim Investigational Site 1
🇧🇪Aalst, Belgium

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