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
- 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
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Patients With Controlled Blood Pressure approximately 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
Name Time Method Mean Difference in Systolic Blood Pressure baseline 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 Pressure baseline 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 Albuminuria Approximately 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
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