Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Additional Effect of A Life Style Program on Antihypertensive Treatment With Telmisartan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01108796
Recruitment Status : Completed
First Posted : April 22, 2010
Results First Posted : December 30, 2011
Last Update Posted : April 10, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Hypertension
Enrollment 1856
Recruitment Details The aim of the study is to investigate the effect of the Lifestyle education tool (Tool/No Tool) for weight reduction on blood pressure control during a six-month treatment with Micardis® / MicardisPlus®. Patients were designated to participate or not participate in a Lifestyle education tool by the investigator under general practice conditions.
Pre-assignment Details A total of 1856 were entered into this trial and 1841 were analysed. For 15 patients case report forms were not available or not usable for analysis
Arm/Group Title Micardis® (Telmisartan) MicardisPlus® (Telmisartan Hydrochlorothiazide)
Hide Arm/Group Description These patients in addition received Tool or No Tool treatment These patients in addition received Tool or No Tool treatment
Period Title: Overall Study
Started 774 1067
Completed 767 1060
Not Completed 7 7
Reason Not Completed
Adverse Event             0             1
Lost to Follow-up             7             6
Arm/Group Title Micardis® (Telmisartan) MicardisPlus® (Telmisartan Hydrochlorothiazide) Tool (With Lifestyle Education Tool on Weight Reduction) No Tool (Without Lifestyle Education Tool on Weight Reduction) Total
Hide Arm/Group Description Patients were enrolled into two groups, receiving treatment with Micardis or MicardisPlus and in addition with Tool or No Tool. The system summarizes the number of patients automatically. The total number is always 1841. [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 774 1067 1187 654 3682
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 774 participants 1067 participants 1187 participants 654 participants 3682 participants
NA [2]   (NA) NA [2]   (NA) 61.14  (10.09) 61.94  (11.01) 61.43  (10.43)
[1]
Measure Description: Patients were enrolled into two groups, receiving treatment with Micardis or MicardisPlus and in addition with Tool or No Tool. The system summarizes the number of patients automatically. The total number is always 1841.
[2]
Mean and Standard Deviation numbers of patients' age per Micardis®/Micardis Plus® arms not available in the statistical analysis report
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 774 participants 1067 participants 1187 participants 654 participants 3682 participants
Female, Tool/No Tool 0 0 679 390 1069
Male, Tool/No Tool 0 0 507 264 771
Female, Micardis®/MicardisPlus® 445 624 0 0 1069
Male, Micardis®/MicardisPlus® 328 443 0 0 771
[1]
Measure Description: Patients were enrolled into two groups, receiving treatment with Micardis or MicardisPlus and in addition with Tool or No Tool. The system summarizes the number of patients automatically. The total number is always 1841.
1.Primary Outcome
Title Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline
Hide Description Changes in blood pressure in patients with systolic values, measured at baseline and final visit, by treatment and by Tool/No Tool
Time Frame 24 weeks (Visit 1 to Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Micardis® (Telmisartan) MicardisPlus® (Telmisartan Hydrochlorothiazide) Tool (With Lifestyle Education Tool on Weight Reduction) No Tool (Without Lifestyle Education Tool on Weight Reduction)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 711 966 1083 594
Mean (Standard Deviation)
Unit of Measure: mmHg
-30.71  (17.81) -30.32  (15.05) -30.35  (16.11) -30.73  (16.58)
2.Primary Outcome
Title Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline
Hide Description Changes in blood pressure in patients with diastolic values, measured at baseline and final visit, by treatment and by Tool/No Tool
Time Frame 24 weeks (Visit 1 to Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Micardis® (Telmisartan) MicardisPlus® (Telmisartan Hydrochlorothiazide) Tool (With Lifestyle Education Tool on Weight Reduction) No Tool (Without Lifestyle Education Tool on Weight Reduction)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 711 966 1083 594
Mean (Standard Deviation)
Unit of Measure: mmHg
-14.73  (8.75) -15.31  (8.87) -15.29  (8.85) -14.65  (8.76)
3.Secondary Outcome
Title Changes in Laboratory Parameters:Low Density Lipoprotein (LDL)
Hide Description Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
Time Frame 24 weeks (Visit 1 to Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Micardis® (Telmisartan) MicardisPlus® (Telmisartan Hydrochlorothiazide) Tool (With Lifestyle Education Tool on Weight Reduction) No Tool (Without Lifestyle Education Tool on Weight Reduction)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 434 577 709 302
Mean (Standard Deviation)
Unit of Measure: mmol/l
-0.41  (0.65) -0.51  (0.77) -0.50  (0.74) -0.40  (0.68)
4.Secondary Outcome
Title Changes in Laboratory Parameters:High Density Lipoprotein (HDL)
Hide Description Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
Time Frame 24 weeks (Visit 1 to Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Micardis® (Telmisartan) MicardisPlus® (Telmisartan Hydrochlorothiazide) Tool (With Lifestyle Education Tool on Weight Reduction) No Tool (Without Lifestyle Education Tool on Weight Reduction)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 441 571 714 298
Mean (Standard Deviation)
Unit of Measure: mmol/l
0.11  (0.25) 0.09  (0.49) 0.12  (0.31) 0.06  (0.56)
5.Secondary Outcome
Title Changes in Laboratory Parameters: Triglycerides
Hide Description Changes in the triglyceride levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
Time Frame 24 weeks (Visit 1 to Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Micardis® (Telmisartan) MicardisPlus® (Telmisartan Hydrochlorothiazide) Tool (With Lifestyle Education Tool on Weight Reduction) No Tool (Without Lifestyle Education Tool on Weight Reduction)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 450 587 727 310
Mean (Standard Deviation)
Unit of Measure: mmol/l
-0.24  (0.61) -0.30  (0.80) -0.32  (0.74) -0.18  (0.69)
6.Secondary Outcome
Title Changes in Laboratory Parameters: Blood Glucose
Hide Description Changes in the fasting blood glucose levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
Time Frame 24 weeks (Visit 1 to Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Micardis® (Telmisartan) MicardisPlus® (Telmisartan Hydrochlorothiazide) Tool (With Lifestyle Education Tool on Weight Reduction) No Tool (Without Lifestyle Education Tool on Weight Reduction)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 457 595 746 306
Mean (Standard Deviation)
Unit of Measure: mmol/l
-0.49  (1.19) -0.45  (1.09) -0.49  (1.17) -0.42  (1.04)
7.Secondary Outcome
Title Assessment of Metabolic Effect
Hide Description Metabolic effect was rated by the investigators as 'positive', 'neutral' and 'negative'
Time Frame 24 weeks (Visit 1 to Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Micardis® (Telmisartan) MicardisPlus® (Telmisartan Hydrochlorothiazide) Tool (With Lifestyle Education Tool on Weight Reduction) No Tool (Without Lifestyle Education Tool on Weight Reduction)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 774 1067 1187 654
Measure Type: Number
Unit of Measure: Participants
Positive 544 695 835 404
Neutral 222 361 339 244
Negative 1 6 3 4
Not available 7 5 10 2
Time Frame 24 weeks/ 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Micardis® (Telmisartan) MicardisPlus® (Telmisartan Hydrochlorothiazide)
Hide Arm/Group Description These patients in addition received Tool or No Tool treatment These patients in addition received Tool or No Tool treatment
All-Cause Mortality
Micardis® (Telmisartan) MicardisPlus® (Telmisartan Hydrochlorothiazide)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Micardis® (Telmisartan) MicardisPlus® (Telmisartan Hydrochlorothiazide)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/774 (0.00%)   1/1067 (0.09%) 
Vascular disorders     
Cerebrovascular accident (fatal stroke)  1  0/774 (0.00%)  1/1067 (0.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Micardis® (Telmisartan) MicardisPlus® (Telmisartan Hydrochlorothiazide)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/774 (0.00%)   0/1067 (0.00%) 
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 Call Center
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: NCT01108796     History of Changes
Other Study ID Numbers: 502.579
First Submitted: March 11, 2010
First Posted: April 22, 2010
Results First Submitted: September 1, 2011
Results First Posted: December 30, 2011
Last Update Posted: April 10, 2014