Trial · NCT00281580
Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension
NCT00281580, Phase 3, Completed, Boehringer Ingelheim; results first posted 2010-04-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension. Trials, record NCT00281580. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00281580
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension
- NCT number
- NCT00281580
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,461 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Hypertension
- Interventions
Amlodipine 5 mg, Placebo, Telmisartan 20 mg, Telmisartan 40 mg, Amlodipine 10 mg, Telmisartan 20 mg, Telmisartan 80 mg, Amlodipine 10 mg, Telmisartan 20 mg, Amlodipine 5 mg, Amlodipine 5 mg, Telmisartan 20 mg, Amlodipine 5 mg, Amlodipine 5 mg, Amlodipine 2.5 mg, Amlodipine 2.5 mg, Amlodipine 10 mg, Amlodipine 2.5 mg, Telmisartan 80 mg, Telmisartan 80 mg, Amlodipine 5 mg, Amlodipine 2.5 mg, Telmisartan 40 mg, Telmisartan 40 mg, Amlodipine 5 mg, Amlodipine 5 mg, Telmisartan 40 mg, Telmisartan 80 mg, Amlodipine 10 mg
- First posted
- 2006-01-25
- Last updated
- 2014-03-27
- Other registries' IDs
- eudract:2008-000874-19
- Results first posted
- 2010-04-28
Source ClinicalTrials.gov
Registered outcomes46
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect) | Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF)) | Observed results |
| Primary | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. |
| Primary | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects) | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | Observed results |
| Primary | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects) | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. |
| Primary | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | End-of-study visit (LOCF) | Observed results |
| Primary | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. |
| Primary | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. |
| Primary | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect) | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | Observed results |
| Primary | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. |
| Primary | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects) | Up to 8 weeks (LOCF) | Observed results |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 registered outcomesOutcomes46
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect) | Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF)) | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC). | mmHg | MEAN |
| PRIMARY | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC). | mmHg | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects) | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC). | mmHg | MEAN |
| PRIMARY | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects) | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC). | mmHg | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | End-of-study visit (LOCF) | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC). | mmHg | MEAN |
| PRIMARY | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC). | mmHg | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC), excluding patients treated with placebo | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP) | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC) | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC) | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC) | mmHg | LEAST_SQUARES_MEAN |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 outcomesResults by group698
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect) | Telmisartan 0 mg (T0) | -13 | Standard Deviation 8.8 | mmHg | |
| Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect) | Telmisartan 20 mg (T20) | -16.4 | Standard Deviation 7.8 | mmHg | |
| Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect) | Telmisartan 40 mg (T40) | -16.2 | Standard Deviation 8.9 | mmHg | |
| Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect) | Telmisartan 80 mg (T80) | -16.9 | Standard Deviation 8.6 | mmHg | |
| Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) | Telmisartan 0 mg (T0) | -12.5 | Standard Error 0.5 | mmHg | |
| Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) | Telmisartan 20 mg (T20) | -16.8 | Standard Error 0.6 | mmHg | |
| Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) | Telmisartan 40 mg (T40) | -16.6 | Standard Error 0.4 | mmHg | |
| Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) | Telmisartan 80 mg (T80) | -17.2 | Standard Error 0.4 | mmHg | |
| Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects) | Placebo (Pl) | -12.3 | Standard Deviation 9.7 | mmHg | |
| Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects) | Amlodipine 2.5 mg (A2.5) | -14.9 | Standard Deviation 8.8 | mmHg |
1 to 10 of 698Source ClinicalTrials.gov
See all 698 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo (Pl) | 46 | |
| Overall Study | STARTED | Telmisartan 20 mg (T20) | 42 | |
| Overall Study | STARTED | Telmisartan 40 mg (T40) | 130 | |
| Overall Study | STARTED | Telmisartan 80 mg (T80) | 135 | |
| Overall Study | STARTED | Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | 44 | |
| Overall Study | STARTED | Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | 46 | |
| Overall Study | STARTED | Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | 44 | |
| Overall Study | STARTED | Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | 47 | |
| Overall Study | STARTED | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | 143 | |
| Overall Study | STARTED | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | 129 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events144
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 | Chest pain | General disorders | PLACEBO | 1 | 46 | |
| other | Chest pain | General disorders | Telmisartan 20 mg (T20) | 3 | 42 | |
| other | Chest pain | General disorders | Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | 0 | 44 | |
| other | Chest pain | General disorders | Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | 0 | 46 | |
| other | Chest pain | General disorders | Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | 0 | 44 | |
| other | Chest pain | General disorders | Telmisartan 40 mg (T40) | 2 | 130 | |
| other | Chest pain | General disorders | Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | 0 | 47 | |
| other | Chest pain | General disorders | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | 1 | 143 | |
| other | Chest pain | General disorders | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | 1 | 129 | |
| other | Chest pain | General disorders | Telmisartan 80 mg (T80) | 0 | 135 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 adverse eventsAdverse event totals48
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PLACEBO | ||
| Total, all-cause mortality | Telmisartan 20 mg (T20) | ||
| Total, all-cause mortality | Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | ||
| Total, all-cause mortality | Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | ||
| Total, all-cause mortality | Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | ||
| Total, all-cause mortality | Telmisartan 40 mg (T40) | ||
| Total, all-cause mortality | Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | ||
| Total, all-cause mortality | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | ||
| Total, all-cause mortality | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | ||
| Total, all-cause mortality | Telmisartan 80 mg (T80) |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse event totalsPapers0
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/NCT00281580
GET https://conductscience.org/api/trials/v1/NCT00281580/registered?page=2