Trial · NCT00553267
Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension
NCT00553267, Phase 3, Completed, Boehringer Ingelheim; results first posted 2009-12-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension. Trials, record NCT00553267. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00553267
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension
- NCT number
- NCT00553267
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 947 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Hypertension
- Interventions
- fixed dose combination of telmisartan+amlodipine, amlodipine
- First posted
- 2007-11-05
- Last updated
- 2014-02-13
- Other registries' IDs
- eudract:2007-002421-68
- Results first posted
- 2009-12-22
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Trough Seated Diastolic Blood Pressure | Baseline and end of study (8 weeks or last value on treatment) | Change from baseline to the end of study in trough DBP |
| Secondary | Change From Baseline in Trough Seated Systolic Blood Pressure | Baseline and end of study (8 weeks or last value on treatment) | Change from baseline to the end of study in trough SBP |
| Secondary | Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg) | End of study (8 weeks or last value on treatment) | The number of patients who reach the target DBP of \<90mmHg |
| Secondary | Trough Seated Diastolic Blood Pressure <80 mmHg | End of study (8 weeks or last value on treatment) | The number of patients who reach the target DBP of \<80mmHg |
| Secondary | Trough Seated DBP Response | End of study (8 weeks or last value on treatment) | The number of patients who reach the target DBP of \<90mmHg or had a reduction in DBP \>= 10mmHg |
| Secondary | Trough Seated SBP Control | End of study (8 weeks or last value on treatment) | The number of patients who reach the target SBP of \<140mmHg |
| Secondary | Trough Seated SBP Response | End of study (8 weeks or last value on treatment) | The number of patients who reach the target SBP of \<140mmHg or had a reduction in SBP \>= 15 mmHg |
| Secondary | Trough Seated BP Normality Classes | End of study (8 weeks or last value on treatment) | The number of patients who reach predefined BP categories |
| Secondary | Oedema Incidence Rate | During randomised treatment period | The number of patients who experienced at least one case of oedema or worsening of oedema for the first time (expressed as number of patients/100 patient-years) |
| Secondary | Peripheral Oedema Incidence Rate | During randomised treatment period | The number of cases of peripheral oedema (expressed as number of cases/100 patient-years) |
Source ClinicalTrials.gov
Outcomes10
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 Diastolic Blood Pressure | Baseline and end of study (8 weeks or last value on treatment) | Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough Seated Systolic Blood Pressure | Baseline and end of study (8 weeks or last value on treatment) | Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg) | End of study (8 weeks or last value on treatment) | Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward | Participants | NUMBER |
| SECONDARY | Trough Seated Diastolic Blood Pressure <80 mmHg | End of study (8 weeks or last value on treatment) | Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward | Participants | NUMBER |
| SECONDARY | Trough Seated DBP Response | End of study (8 weeks or last value on treatment) | Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward | Participants | NUMBER |
| SECONDARY | Trough Seated SBP Control | End of study (8 weeks or last value on treatment) | Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward | Participants | NUMBER |
| SECONDARY | Trough Seated SBP Response | End of study (8 weeks or last value on treatment) | Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward | Participants | NUMBER |
| SECONDARY | Trough Seated BP Normality Classes | End of study (8 weeks or last value on treatment) | Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward | Participants | NUMBER |
| SECONDARY | Oedema Incidence Rate | During randomised treatment period | Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward | Number of patients/100 patient-years | NUMBER |
| SECONDARY | Peripheral Oedema Incidence Rate | During randomised treatment period | Number of cases/100 patient-years | NUMBER |
Source ClinicalTrials.gov
Results by group57
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 Diastolic Blood Pressure | Amlodipine 10mg | -6.48 | Standard Error 0.45 | mmHg | |
| Change From Baseline in Trough Seated Diastolic Blood Pressure | Telmisartan 40mg and Amlodipine 10mg | -9.24 | Standard Error 0.45 | mmHg | |
| Change From Baseline in Trough Seated Diastolic Blood Pressure | Telmisartan 80mg and Amlodipine 10mg | -9.33 | Standard Error 0.45 | mmHg | |
| Change From Baseline in Trough Seated Systolic Blood Pressure | Amlodipine 10mg | -7.44 | Standard Error 0.66 | mmHg | |
| Change From Baseline in Trough Seated Systolic Blood Pressure | Telmisartan 40mg and Amlodipine 10mg | -11.09 | Standard Error 0.66 | mmHg | |
| Change From Baseline in Trough Seated Systolic Blood Pressure | Telmisartan 80mg and Amlodipine 10mg | -11.29 | Standard Error 0.66 | mmHg | |
| Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg) | Amlodipine 10mg | Yes (DBP<90 mmHg) | 156 | Participants | |
| Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg) | Telmisartan 40mg and Amlodipine 10mg | Yes (DBP<90 mmHg) | 195 | Participants | |
| Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg) | Telmisartan 80mg and Amlodipine 10mg | Yes (DBP<90 mmHg) | 206 | Participants | |
| Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg) | Amlodipine 10mg | No (DBP>=90 mmHg) | 149 | Participants |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Amlodipine 10mg | 315 | |
| Overall Study | STARTED | Telmisartan 40mg and Amlodipine 10mg | 315 | |
| Overall Study | STARTED | Telmisartan 80mg and Amlodipine 10mg | 317 | |
| Overall Study | COMPLETED | Amlodipine 10mg | 301 | |
| Overall Study | COMPLETED | Telmisartan 40mg and Amlodipine 10mg | 297 | |
| Overall Study | COMPLETED | Telmisartan 80mg and Amlodipine 10mg | 307 | |
| Overall Study | NOT COMPLETED | Amlodipine 10mg | 14 | |
| Overall Study | NOT COMPLETED | Telmisartan 40mg and Amlodipine 10mg | 18 | |
| Overall Study | NOT COMPLETED | Telmisartan 80mg and Amlodipine 10mg | 10 |
Source ClinicalTrials.gov
Adverse events15
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 | Peripheral oedema | General disorders | Amlodipine 10mg | 22 | 315 | |
| other | Peripheral oedema | General disorders | Telmisartan 40mg and Amlodipine 10mg | 21 | 315 | |
| other | Peripheral oedema | General disorders | Telmisartan 80mg and Amlodipine 10mg | 27 | 317 | |
| serious | Cardiac failure | Cardiac disorders | Amlodipine 10mg | 0 | 315 | |
| serious | Cardiac failure | Cardiac disorders | Telmisartan 40mg and Amlodipine 10mg | 1 | 315 | |
| serious | Cardiac failure | Cardiac disorders | Telmisartan 80mg and Amlodipine 10mg | 0 | 317 | |
| serious | Local swelling | General disorders | Amlodipine 10mg | 0 | 315 | |
| serious | Local swelling | General disorders | Telmisartan 40mg and Amlodipine 10mg | 1 | 315 | |
| serious | Local swelling | General disorders | Telmisartan 80mg and Amlodipine 10mg | 0 | 317 | |
| serious | Bronchitis | Infections and infestations | Amlodipine 10mg | 1 | 315 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amlodipine 10mg | ||
| Total, all-cause mortality | Telmisartan 40mg and Amlodipine 10mg | ||
| Total, all-cause mortality | Telmisartan 80mg and Amlodipine 10mg | ||
| Total, other adverse events | Amlodipine 10mg | 22 | |
| Total, other adverse events | Telmisartan 40mg and Amlodipine 10mg | 21 | |
| Total, other adverse events | Telmisartan 80mg and Amlodipine 10mg | 27 | |
| Total, serious adverse events | Amlodipine 10mg | 1 | |
| Total, serious adverse events | Telmisartan 40mg and Amlodipine 10mg | 3 | |
| Total, serious adverse events | Telmisartan 80mg and Amlodipine 10mg | 0 |
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/NCT00553267
GET https://conductscience.org/api/trials/v1/NCT00553267/results?page=2