Trial · NCT01108796
Additional Effect of A Life Style Program on Antihypertensive Treatment With Telmisartan
NCT01108796, Completed, Boehringer Ingelheim; results first posted 2011-12-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Additional Effect of A Life Style Program on Antihypertensive Treatment With Telmisartan. Trials, record NCT01108796. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01108796
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Additional Effect of A Life Style Program on Antihypertensive Treatment With Telmisartan
- NCT number
- NCT01108796
- Status
- Completed
- Enrollment
- 1,856 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Hypertension
- First posted
- 2010-04-22
- Last updated
- 2014-04-10
- Results first posted
- 2011-12-30
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline | 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 |
| Primary | Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline | 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 |
| Secondary | Changes in Laboratory Parameters:Low Density Lipoprotein (LDL) | 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 |
| Secondary | Changes in Laboratory Parameters:High Density Lipoprotein (HDL) | 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 |
| Secondary | Changes in Laboratory Parameters: Triglycerides | 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 |
| Secondary | Changes in Laboratory Parameters: Blood Glucose | 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 |
| Secondary | Assessment of Metabolic Effect | 24 weeks (Visit 1 to Visit 3) | Metabolic effect was rated by the investigators as 'positive', 'neutral' and 'negative' |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline | 24 weeks (Visit 1 to Visit 3) | mmHg | MEAN | |
| PRIMARY | Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline | 24 weeks (Visit 1 to Visit 3) | mmHg | MEAN | |
| SECONDARY | Changes in Laboratory Parameters:Low Density Lipoprotein (LDL) | 24 weeks (Visit 1 to Visit 3) | mmol/l | MEAN | |
| SECONDARY | Changes in Laboratory Parameters:High Density Lipoprotein (HDL) | 24 weeks (Visit 1 to Visit 3) | mmol/l | MEAN | |
| SECONDARY | Changes in Laboratory Parameters: Triglycerides | 24 weeks (Visit 1 to Visit 3) | mmol/l | MEAN | |
| SECONDARY | Changes in Laboratory Parameters: Blood Glucose | 24 weeks (Visit 1 to Visit 3) | mmol/l | MEAN | |
| SECONDARY | Assessment of Metabolic Effect | 24 weeks (Visit 1 to Visit 3) | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline | Micardis® (Telmisartan) | -30.71 | Standard Deviation 17.81 | mmHg | |
| Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline | MicardisPlus® (Telmisartan Hydrochlorothiazide) | -30.32 | Standard Deviation 15.05 | mmHg | |
| Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline | Tool (With Lifestyle Education Tool on Weight Reduction) | -30.35 | Standard Deviation 16.11 | mmHg | |
| Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline | No Tool (Without Lifestyle Education Tool on Weight Reduction) | -30.73 | Standard Deviation 16.58 | mmHg | |
| Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline | Micardis® (Telmisartan) | -14.73 | Standard Deviation 8.75 | mmHg | |
| Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline | MicardisPlus® (Telmisartan Hydrochlorothiazide) | -15.31 | Standard Deviation 8.87 | mmHg | |
| Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline | Tool (With Lifestyle Education Tool on Weight Reduction) | -15.29 | Standard Deviation 8.85 | mmHg | |
| Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline | No Tool (Without Lifestyle Education Tool on Weight Reduction) | -14.65 | Standard Deviation 8.76 | mmHg | |
| Changes in Laboratory Parameters:Low Density Lipoprotein (LDL) | Micardis® (Telmisartan) | -0.41 | Standard Deviation 0.65 | mmol/l | |
| Changes in Laboratory Parameters:Low Density Lipoprotein (LDL) | MicardisPlus® (Telmisartan Hydrochlorothiazide) | -0.51 | Standard Deviation 0.77 | mmol/l |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Micardis® (Telmisartan) | 774 | |
| Overall Study | STARTED | MicardisPlus® (Telmisartan Hydrochlorothiazide) | 1,067 | |
| Overall Study | COMPLETED | Micardis® (Telmisartan) | 767 | |
| Overall Study | COMPLETED | MicardisPlus® (Telmisartan Hydrochlorothiazide) | 1,060 | |
| Overall Study | NOT COMPLETED | Micardis® (Telmisartan) | 7 | |
| Overall Study | NOT COMPLETED | MicardisPlus® (Telmisartan Hydrochlorothiazide) | 7 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Cerebrovascular accident (fatal stroke) | Vascular disorders | Micardis® (Telmisartan) | 0 | 774 | |
| serious | Cerebrovascular accident (fatal stroke) | Vascular disorders | MicardisPlus® (Telmisartan Hydrochlorothiazide) | 1 | 1,067 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Micardis® (Telmisartan) | ||
| Total, all-cause mortality | MicardisPlus® (Telmisartan Hydrochlorothiazide) | ||
| Total, other adverse events | Micardis® (Telmisartan) | 0 | 774 |
| Total, other adverse events | MicardisPlus® (Telmisartan Hydrochlorothiazide) | 0 | 1,067 |
| Total, serious adverse events | Micardis® (Telmisartan) | 0 | 774 |
| Total, serious adverse events | MicardisPlus® (Telmisartan Hydrochlorothiazide) | 1 | 1,067 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Micardis® (Telmisartan) vs MicardisPlus® (Telmisartan Hydrochlorothiazide): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01108796
GET https://conductscience.org/api/trials/v1/NCT01108796/results?page=2