Trial · NCT00860262
Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension
NCT00860262, Phase 3, Completed, Boehringer Ingelheim; results first posted 2011-01-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension. Trials, record NCT00860262. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00860262
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension
- NCT number
- NCT00860262
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 858 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Hypertension
- Interventions
- amlodipine, telmisartan, telmisartan and amlodipine
- First posted
- 2009-03-12
- Last updated
- 2014-05-20
- Other registries' IDs
- eudract:2008-000873-40
- Results first posted
- 2011-01-04
Source ClinicalTrials.gov
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 | baseline and week 8 | Overall mean reduction from a common mean baseline in SBP |
| Secondary | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6 | baseline and week 6 | Overall mean reduction from a common mean baseline in SBP |
| Secondary | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4 | baseline and week 4 | Overall mean reduction from a common mean baseline in SBP |
| Secondary | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2 | baseline and week 2 | Overall mean reduction from a common mean baseline in SBP |
| Secondary | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1 | baseline and week 1 | Overall mean reduction from a common mean baseline in SBP |
| Secondary | Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8 | baseline and week 8 | Overall mean reduction from a common mean baseline in DBP |
| Secondary | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6 | baseline and week 6 | Overall mean reduction from a common mean baseline in DBP |
| Secondary | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4 | baseline and week 4 | Overall mean reduction from a common mean baseline in DBP |
| Secondary | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2 | baseline and week 2 | Overall mean reduction from a common mean baseline in DBP |
| Secondary | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1 | baseline and week 1 | Overall mean reduction from a common mean baseline in DBP |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 registered outcomesOutcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 | baseline and week 8 | Full analysis set (FAS) included all randomised patients who had at least one seated trough cuff SBP following administration of study drug. | mmHg (millimeters of mercury) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6 | baseline and week 6 | Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement. | mmHg (millimeters of mercury) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4 | baseline and week 4 | Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement. | mmHg (millimeters of mercury) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2 | baseline and week 2 | Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement. | mmHg (millimeters of mercury) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1 | baseline and week 1 | Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement. | mmHg (millimeters of mercury) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8 | baseline and week 8 | Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement. | mmHg (millimeters of mercury) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6 | baseline and week 6 | Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement. | mmHg (millimeters of mercury) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4 | baseline and week 4 | Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement. | mmHg (millimeters of mercury) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2 | baseline and week 2 | Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement. | mmHg (millimeters of mercury) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1 | baseline and week 1 | Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement. | mmHg (millimeters of mercury) | LEAST_SQUARES_MEAN |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 outcomesResults by group210
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 | T80+A10 | -47.5 | Standard Error 0.69 | mmHg (millimeters of mercury) | |
| Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 | Telmisartan 80 mg | -36.9 | Standard Error 0.96 | mmHg (millimeters of mercury) | |
| Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 | Amlodipine 10 mg | -43.2 | Standard Error 0.95 | mmHg (millimeters of mercury) | |
| Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6 | T80+A10 | -46.9 | Standard Error 0.73 | mmHg (millimeters of mercury) | |
| Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6 | Telmisartan 80 mg | -36.3 | Standard Error 1.01 | mmHg (millimeters of mercury) | |
| Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6 | Amlodipine 10 mg | -42.1 | Standard Error 1.01 | mmHg (millimeters of mercury) | |
| Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4 | T80+A10 | -44.5 | Standard Error 0.73 | mmHg (millimeters of mercury) | |
| Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4 | Telmisartan 80 mg | -34.4 | Standard Error 1.01 | mmHg (millimeters of mercury) | |
| Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4 | Amlodipine 10 mg | -39.8 | Standard Error 1.01 | mmHg (millimeters of mercury) | |
| Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2 | T80+A5 | -37.9 | Standard Error 0.71 | mmHg (millimeters of mercury) |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | T80+A10 | 421 | |
| Overall Study | STARTED | Telmisartan 80 mg | 217 | |
| Overall Study | STARTED | Amlodipine 10 mg | 220 | |
| Overall Study | COMPLETED | T80+A10 | 401 | |
| Overall Study | COMPLETED | Telmisartan 80 mg | 195 | |
| Overall Study | COMPLETED | Amlodipine 10 mg | 202 | |
| Overall Study | NOT COMPLETED | T80+A10 | 20 | |
| Overall Study | NOT COMPLETED | Telmisartan 80 mg | 22 | |
| Overall Study | NOT COMPLETED | Amlodipine 10 mg | 18 |
Source ClinicalTrials.gov
Adverse events30
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 |
|---|---|---|---|---|---|---|
| other | Oedema peripheral | General disorders | T80+A10 | 55 | 421 | |
| other | Oedema peripheral | General disorders | Telmisartan 80 mg | 8 | 217 | |
| other | Oedema peripheral | General disorders | Amlodipine 10 mg | 33 | 220 | |
| other | Headache | Nervous system disorders | T80+A10 | 16 | 421 | |
| other | Headache | Nervous system disorders | Telmisartan 80 mg | 18 | 217 | |
| other | Headache | Nervous system disorders | Amlodipine 10 mg | 12 | 220 | |
| serious | Atrial fibrillation | Cardiac disorders | T80+A10 | 0 | 421 | |
| serious | Atrial fibrillation | Cardiac disorders | Telmisartan 80 mg | 0 | 217 | |
| serious | Atrial fibrillation | Cardiac disorders | Amlodipine 10 mg | 1 | 220 | |
| serious | Atrioventricular block second degree | Cardiac disorders | T80+A10 | 0 | 421 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | T80+A10 | ||
| Total, all-cause mortality | Telmisartan 80 mg | ||
| Total, all-cause mortality | Amlodipine 10 mg | ||
| Total, other adverse events | T80+A10 | 67 | 421 |
| Total, other adverse events | Telmisartan 80 mg | 25 | 217 |
| Total, other adverse events | Amlodipine 10 mg | 42 | 220 |
| Total, serious adverse events | T80+A10 | 3 | 421 |
| Total, serious adverse events | Telmisartan 80 mg | 2 | 217 |
| Total, serious adverse events | Amlodipine 10 mg | 2 | 220 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00860262
GET https://conductscience.org/api/trials/v1/NCT00860262/registered?page=2