Trial Outcomes & Findings for Additional Effect of A Life Style Program on Antihypertensive Treatment With Telmisartan (NCT NCT01108796)
NCT ID: NCT01108796
Last Updated: 2014-04-10
Results Overview
Changes in blood pressure in patients with systolic values, measured at baseline and final visit, by treatment and by Tool/No Tool
Recruitment status
COMPLETED
Target enrollment
1856 participants
Primary outcome timeframe
24 weeks (Visit 1 to Visit 3)
Results posted on
2014-04-10
Participant Flow
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.
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
Participant milestones
| Measure |
Micardis® (Telmisartan)
These patients in addition received Tool or No Tool treatment
|
MicardisPlus® (Telmisartan Hydrochlorothiazide)
These patients in addition received Tool or No Tool treatment
|
|---|---|---|
|
Overall Study
STARTED
|
774
|
1067
|
|
Overall Study
COMPLETED
|
767
|
1060
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
| Measure |
Micardis® (Telmisartan)
These patients in addition received Tool or No Tool treatment
|
MicardisPlus® (Telmisartan Hydrochlorothiazide)
These patients in addition received Tool or No Tool treatment
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
7
|
6
|
Baseline Characteristics
Additional Effect of A Life Style Program on Antihypertensive Treatment With Telmisartan
Baseline characteristics by cohort
| Measure |
Micardis® (Telmisartan)
n=774 Participants
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.
|
MicardisPlus® (Telmisartan Hydrochlorothiazide)
n=1067 Participants
|
Tool (With Lifestyle Education Tool on Weight Reduction)
n=1187 Participants
|
No Tool (Without Lifestyle Education Tool on Weight Reduction)
n=654 Participants
|
Total
n=3682 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
NA Years
STANDARD_DEVIATION NA • n=99 Participants
|
NA Years
STANDARD_DEVIATION NA • n=107 Participants
|
61.14 Years
STANDARD_DEVIATION 10.09 • n=206 Participants
|
61.94 Years
STANDARD_DEVIATION 11.01 • n=7 Participants
|
61.43 Years
STANDARD_DEVIATION 10.43 • n=31 Participants
|
|
Sex/Gender, Customized
Female, Tool/No Tool
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
679 Participants
n=206 Participants
|
390 Participants
n=7 Participants
|
1069 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Male, Tool/No Tool
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
507 Participants
n=206 Participants
|
264 Participants
n=7 Participants
|
771 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Female, Micardis®/MicardisPlus®
|
445 Participants
n=99 Participants
|
624 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1069 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Male, Micardis®/MicardisPlus®
|
328 Participants
n=99 Participants
|
443 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
771 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 24 weeks (Visit 1 to Visit 3)Changes in blood pressure in patients with systolic values, measured at baseline and final visit, by treatment and by Tool/No Tool
Outcome measures
| Measure |
Micardis® (Telmisartan)
n=711 Participants
|
MicardisPlus® (Telmisartan Hydrochlorothiazide)
n=966 Participants
|
Tool (With Lifestyle Education Tool on Weight Reduction)
n=1083 Participants
|
No Tool (Without Lifestyle Education Tool on Weight Reduction)
n=594 Participants
|
|---|---|---|---|---|
|
Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline
|
-30.71 mmHg
Standard Deviation 17.81
|
-30.32 mmHg
Standard Deviation 15.05
|
-30.35 mmHg
Standard Deviation 16.11
|
-30.73 mmHg
Standard Deviation 16.58
|
PRIMARY outcome
Timeframe: 24 weeks (Visit 1 to Visit 3)Changes in blood pressure in patients with diastolic values, measured at baseline and final visit, by treatment and by Tool/No Tool
Outcome measures
| Measure |
Micardis® (Telmisartan)
n=711 Participants
|
MicardisPlus® (Telmisartan Hydrochlorothiazide)
n=966 Participants
|
Tool (With Lifestyle Education Tool on Weight Reduction)
n=1083 Participants
|
No Tool (Without Lifestyle Education Tool on Weight Reduction)
n=594 Participants
|
|---|---|---|---|---|
|
Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline
|
-14.73 mmHg
Standard Deviation 8.75
|
-15.31 mmHg
Standard Deviation 8.87
|
-15.29 mmHg
Standard Deviation 8.85
|
-14.65 mmHg
Standard Deviation 8.76
|
SECONDARY outcome
Timeframe: 24 weeks (Visit 1 to Visit 3)Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
Outcome measures
| Measure |
Micardis® (Telmisartan)
n=434 Participants
|
MicardisPlus® (Telmisartan Hydrochlorothiazide)
n=577 Participants
|
Tool (With Lifestyle Education Tool on Weight Reduction)
n=709 Participants
|
No Tool (Without Lifestyle Education Tool on Weight Reduction)
n=302 Participants
|
|---|---|---|---|---|
|
Changes in Laboratory Parameters:Low Density Lipoprotein (LDL)
|
-0.41 mmol/l
Standard Deviation 0.65
|
-0.51 mmol/l
Standard Deviation 0.77
|
-0.50 mmol/l
Standard Deviation 0.74
|
-0.40 mmol/l
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: 24 weeks (Visit 1 to Visit 3)Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
Outcome measures
| Measure |
Micardis® (Telmisartan)
n=441 Participants
|
MicardisPlus® (Telmisartan Hydrochlorothiazide)
n=571 Participants
|
Tool (With Lifestyle Education Tool on Weight Reduction)
n=714 Participants
|
No Tool (Without Lifestyle Education Tool on Weight Reduction)
n=298 Participants
|
|---|---|---|---|---|
|
Changes in Laboratory Parameters:High Density Lipoprotein (HDL)
|
0.11 mmol/l
Standard Deviation 0.25
|
0.09 mmol/l
Standard Deviation 0.49
|
0.12 mmol/l
Standard Deviation 0.31
|
0.06 mmol/l
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: 24 weeks (Visit 1 to Visit 3)Changes in the triglyceride levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
Outcome measures
| Measure |
Micardis® (Telmisartan)
n=450 Participants
|
MicardisPlus® (Telmisartan Hydrochlorothiazide)
n=587 Participants
|
Tool (With Lifestyle Education Tool on Weight Reduction)
n=727 Participants
|
No Tool (Without Lifestyle Education Tool on Weight Reduction)
n=310 Participants
|
|---|---|---|---|---|
|
Changes in Laboratory Parameters: Triglycerides
|
-0.24 mmol/l
Standard Deviation 0.61
|
-0.30 mmol/l
Standard Deviation 0.80
|
-0.32 mmol/l
Standard Deviation 0.74
|
-0.18 mmol/l
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: 24 weeks (Visit 1 to Visit 3)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
Outcome measures
| Measure |
Micardis® (Telmisartan)
n=457 Participants
|
MicardisPlus® (Telmisartan Hydrochlorothiazide)
n=595 Participants
|
Tool (With Lifestyle Education Tool on Weight Reduction)
n=746 Participants
|
No Tool (Without Lifestyle Education Tool on Weight Reduction)
n=306 Participants
|
|---|---|---|---|---|
|
Changes in Laboratory Parameters: Blood Glucose
|
-0.49 mmol/l
Standard Deviation 1.19
|
-0.45 mmol/l
Standard Deviation 1.09
|
-0.49 mmol/l
Standard Deviation 1.17
|
-0.42 mmol/l
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: 24 weeks (Visit 1 to Visit 3)Metabolic effect was rated by the investigators as 'positive', 'neutral' and 'negative'
Outcome measures
| Measure |
Micardis® (Telmisartan)
n=774 Participants
|
MicardisPlus® (Telmisartan Hydrochlorothiazide)
n=1067 Participants
|
Tool (With Lifestyle Education Tool on Weight Reduction)
n=1187 Participants
|
No Tool (Without Lifestyle Education Tool on Weight Reduction)
n=654 Participants
|
|---|---|---|---|---|
|
Assessment of Metabolic Effect
Positive
|
544 Participants
|
695 Participants
|
835 Participants
|
404 Participants
|
|
Assessment of Metabolic Effect
Neutral
|
222 Participants
|
361 Participants
|
339 Participants
|
244 Participants
|
|
Assessment of Metabolic Effect
Negative
|
1 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
|
Assessment of Metabolic Effect
Not available
|
7 Participants
|
5 Participants
|
10 Participants
|
2 Participants
|
Adverse Events
Micardis® (Telmisartan)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MicardisPlus® (Telmisartan Hydrochlorothiazide)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Micardis® (Telmisartan)
n=774 participants at risk
These patients in addition received Tool or No Tool treatment
|
MicardisPlus® (Telmisartan Hydrochlorothiazide)
n=1067 participants at risk
These patients in addition received Tool or No Tool treatment
|
|---|---|---|
|
Vascular disorders
Cerebrovascular accident (fatal stroke)
|
0.00%
0/774 • 24 weeks/ 6 months
|
0.09%
1/1067 • 24 weeks/ 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER