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Trial record 58 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

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

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ClinicalTrials.gov Identifier: NCT00886288
Recruitment Status : Completed
First Posted : April 22, 2009
Results First Posted : November 18, 2009
Last Update Posted : June 17, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Hypertension
Enrollment 2874
Recruitment Details  
Pre-assignment Details 163 patients without information on albuminuria at baseline were enrolled to the study in addition. However, for these patients information on study completion is not available.
Arm/Group Title Patients Without Albuminuria Treated With Telmisartan Patients With Albuminuria Treated With Telmisartan
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 2027 [1] 684 [1]
Completed 1284 457
Not Completed 743 227
Reason Not Completed
no respect of the 12 weeks period             657             227
Lost to Follow-up             86             0
[1]
Baseline Population
Arm/Group Title Patients Without Albuminuria Treated With Telmisartan Patients With Albuminuria Treated With Telmisartan Total
Hide Arm/Group Description baseline population baseline population Total of all reporting groups
Overall Number of Baseline Participants 2027 684 2711
Hide Baseline Analysis Population Description
Baseline characteristics are presented for patients with available information on albuminuria at baseline. Respective data were not collected for patients without information on albuminuria at baseline.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2027 participants 684 participants 2711 participants
63  (11.7) 65.9  (11.9) 63.8  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2027 participants 684 participants 2711 participants
Female
966
  47.7%
329
  48.1%
1295
  47.8%
Male
1061
  52.3%
355
  51.9%
1416
  52.2%
1.Primary Outcome
Title Percentage of Patients With Controlled Blood Pressure
Hide Description

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)
Time Frame approximately 12 weeks (10 to 14 weeks) after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)
Arm/Group Title Patients Without Albuminuria Treated With Telmisartan Patients With Albuminuria Treated With Telmisartan
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 1281 457
Measure Type: Number
Unit of Measure: Percentage of patients
46.1 24.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients Without Albuminuria Treated With Telmisartan, Patients With Albuminuria Treated With Telmisartan
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Mean Difference in Systolic Blood Pressure
Hide Description 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
Time Frame baseline and approximately 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)
Arm/Group Title Patients Without Albuminuria Treated With Telmisartan Patients With Albuminuria Treated With Telmisartan
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 1281 457
Mean (Standard Deviation)
Unit of Measure: mmHg
20.8  (13.3) 20.5  (13.0)
3.Secondary Outcome
Title Mean Difference in Diastolic Blood Pressure
Hide Description 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
Time Frame baseline and approximately 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)
Arm/Group Title Patients Without Albuminuria Treated With Telmisartan Patients With Albuminuria Treated With Telmisartan
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 1281 457
Mean (Standard Deviation)
Unit of Measure: mmHg
11.7  (9.22) 12.5  (8.53)
4.Secondary Outcome
Title Percentage of Patients With a Decrease of Systolic Blood Pressure (SBP) ≥ 10 mmHg (Responders)
Hide Description 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
Time Frame approximately 12 weeks (10 to 14 weeks) after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)
Arm/Group Title Patients Without Albuminuria Treated With Telmisartan Patients With Albuminuria Treated With Telmisartan
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 1281 457
Measure Type: Number
Unit of Measure: Percentage of patients
87.7 88.6
5.Secondary Outcome
Title Percentage of Patients Presenting an Adverse Event (AE)
Hide Description Percentage of patients with any adverse events during the study period, related or not to investigational drug
Time Frame baseline to the end of study period
Hide Outcome Measure Data
Hide Analysis Population Description
1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)
Arm/Group Title Patients Without Albuminuria Treated With Telmisartan Patients With Albuminuria Treated With Telmisartan
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 1284 457
Measure Type: Number
Unit of Measure: percentage of patients
0.7 0.44
6.Secondary Outcome
Title Percentage of Patients With Positive to Negative Shift in Albuminuria
Hide Description Percentage of patients shifting from with (positive) albuminuria at baseline to without (negative) albuminuria after approximately 12 weeks
Time Frame Approximately 12 weeks (10 to 14 weeks) after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with albuminuria at initial visit and for which information on albuminuria was known at visit 2, 12 weeks after the initial visit.
Arm/Group Title Patients With Albuminuria Treated With Telmisartan
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 331
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
53.8
(48.4 to 59.2)
Time Frame From signing of informed consent through the end of the study
Adverse Event Reporting Description 2874 participants at risk= patients without major protocol violation
 
Arm/Group Title Patients Without Albuminuria Treated With Telmisartan Patients With Albuminuria Treated With Telmisartan [Not Specified]
Hide Arm/Group Description [Not Specified] [Not Specified] patients without baseline albuminuria data
All-Cause Mortality
Patients Without Albuminuria Treated With Telmisartan Patients With Albuminuria Treated With Telmisartan [Not Specified]
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Patients Without Albuminuria Treated With Telmisartan Patients With Albuminuria Treated With Telmisartan [Not Specified]
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/2027 (0.05%)   1/684 (0.15%)   0/163 (0.00%) 
Cardiac disorders       
Myocardial infarct  1  1/2027 (0.05%)  0/684 (0.00%)  0/163 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Ovarian metastases  1  0/2027 (0.00%)  1/684 (0.15%)  0/163 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Patients Without Albuminuria Treated With Telmisartan Patients With Albuminuria Treated With Telmisartan [Not Specified]
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2027 (0.00%)   0/684 (0.00%)   0/163 (0.00%) 
Observational study of daily medical practice, a lot of patients did not return to their GP for the second visit during the time period of 10 to 14 weeks after the first visit
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Pharmaceuticals
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00886288     History of Changes
Other Study ID Numbers: 502.521
First Submitted: April 21, 2009
First Posted: April 22, 2009
Results First Submitted: August 27, 2009
Results First Posted: November 18, 2009
Last Update Posted: June 17, 2014