Trial · NCT00558428
Telmisartan/Amlodipine (80/5) vs. Telmisartan/Amlodipine (40/5) vs. Amlodipine 10 or 5 in Resistant Hypertension
NCT00558428, Phase 3, Completed, Boehringer Ingelheim; results first posted 2009-12-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Telmisartan/Amlodipine (80/5) vs. Telmisartan/Amlodipine (40/5) vs. Amlodipine 10 or 5 in Resistant Hypertension. Trials, record NCT00558428. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00558428
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Telmisartan/Amlodipine (80/5) vs. Telmisartan/Amlodipine (40/5) vs. Amlodipine 10 or 5 in Resistant Hypertension
- NCT number
- NCT00558428
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,098 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Hypertension
- Interventions
- fixed dose combination of telmisartan+amlodipine, amlodipine
- First posted
- 2007-11-15
- Last updated
- 2014-06-27
- Other registries' IDs
- eudract:2007-002409-36
- Results first posted
- 2009-12-15
Source ClinicalTrials.gov
Registered outcomes8
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 (DBP) | End of study (8 weeks or last value on treatment) | Change from baseline to the end of study in trough DBP |
| Primary | Number of Patients With Oedema | During randomised treatment period (8 weeks was the planned end of treatment, some of the measurements analysed as end of study can be at 4 weeks or at any point on randomised treatment) | Patients from the treated set who experienced at least one case of general oedema. |
| Secondary | Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) | 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 | End of study (8 weeks or last value on treatment) | The number of patients who reach the target DBP of \<90mmHg |
| 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 Blood Pressure (BP) Normality Classes | End of study (8 weeks or last value on treatment) | The number of patients who reach predefined BP categories: * Optimal - SBP\<120 and DBP\<80 mmHg * Normal - SBP\<130 and DBP\<85 mmHg * High-normal - SBP\<140 DBP\<90 mmHg * Stage 1 hypertension - SBP\<160 and DBP\<100 * Stage 2 hypertension SBP\>=160 and DBP\>=100 mmHg |
Source ClinicalTrials.gov
Outcomes8
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 (DBP) | 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. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) | 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. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Trough Seated Diastolic Blood Pressure 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. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure | patients | 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. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure | patients | 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. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure | patients | 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. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure | patients | NUMBER |
| SECONDARY | Trough Seated Blood Pressure (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. The full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure | patients | NUMBER |
| PRIMARY | Number of Patients With Oedema | During randomised treatment period (8 weeks was the planned end of treatment, some of the measurements analysed as end of study can be at 4 weeks or at any point on randomised treatment) | The treated set (TS) consisted of all patients that took at least one dose of the double-blind treatment (n=1097) | patients | NUMBER |
Source ClinicalTrials.gov
Results by group68
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 (DBP) | Amlodipine 5mg | -5.71 | Standard Error 0.49 | mmHg | |
| Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) | Amlodipine 10mg | -7.95 | Standard Error 0.49 | mmHg | |
| Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) | Telmisartan 40mg and Amlodipine 5mg | -9.35 | Standard Error 0.48 | mmHg | |
| Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) | Telmisartan 80mg and Amlodipine 5mg | -10.63 | Standard Error 0.48 | mmHg | |
| Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) | Amlodipine 5mg | -6.18 | Standard Error 0.73 | mmHg | |
| Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) | Amlodipine 10mg | -11.11 | Standard Error 0.72 | mmHg | |
| Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) | Telmisartan 40mg and Amlodipine 5mg | -13.56 | Standard Error 0.71 | mmHg | |
| Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) | Telmisartan 80mg and Amlodipine 5mg | -14.99 | Standard Error 0.71 | mmHg | |
| Trough Seated Diastolic Blood Pressure Control | Amlodipine 5mg | Yes (DBP<90 mmHg) | 107 | patients | |
| Trough Seated Diastolic Blood Pressure Control | Amlodipine 10mg | Yes (DBP<90 mmHg) | 148 | patients |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Amlodipine 5mg | 267 | |
| Overall Study | STARTED | Amlodipine 10mg | 276 | |
| Overall Study | STARTED | Telmisartan 40mg and Amlodipine 5mg | 277 | |
| Overall Study | STARTED | Telmisartan 80mg and Amlodipine 5mg | 277 | |
| Overall Study | COMPLETED | Amlodipine 5mg | 255 | |
| Overall Study | COMPLETED | Amlodipine 10mg | 252 | |
| Overall Study | COMPLETED | Telmisartan 40mg and Amlodipine 5mg | 273 | |
| Overall Study | COMPLETED | Telmisartan 80mg and Amlodipine 5mg | 266 | |
| Overall Study | NOT COMPLETED | Amlodipine 5mg | 12 | |
| Overall Study | NOT COMPLETED | Amlodipine 10mg | 24 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events28
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 | Amlodipine 5mg | 22 | 267 | |
| other | Oedema peripheral | General disorders | Amlodipine 10mg | 74 | 276 | |
| other | Oedema peripheral | General disorders | Telmisartan 40mg and Amlodipine 5mg | 14 | 277 | |
| other | Oedema peripheral | General disorders | Telmisartan 80mg and Amlodipine 5mg | 10 | 277 | |
| serious | Atrial fibrilation | Cardiac disorders | Amlodipine 5mg | 1 | 267 | |
| serious | Atrial fibrilation | Cardiac disorders | Amlodipine 10mg | 0 | 276 | |
| serious | Atrial fibrilation | Cardiac disorders | Telmisartan 40mg and Amlodipine 5mg | 0 | 277 | |
| serious | Atrial fibrilation | Cardiac disorders | Telmisartan 80mg and Amlodipine 5mg | 0 | 277 | |
| serious | Chest discomfort | General disorders | Amlodipine 5mg | 0 | 267 | |
| serious | Chest discomfort | General disorders | Amlodipine 10mg | 0 | 276 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amlodipine 5mg | ||
| Total, all-cause mortality | Amlodipine 10mg | ||
| Total, all-cause mortality | Telmisartan 40mg and Amlodipine 5mg | ||
| Total, all-cause mortality | Telmisartan 80mg and Amlodipine 5mg | ||
| Total, other adverse events | Amlodipine 5mg | 22 | 267 |
| Total, other adverse events | Amlodipine 10mg | 74 | 276 |
| Total, other adverse events | Telmisartan 40mg and Amlodipine 5mg | 14 | 277 |
| Total, other adverse events | Telmisartan 80mg and Amlodipine 5mg | 10 | 277 |
| Total, serious adverse events | Amlodipine 5mg | 2 | 267 |
| Total, serious adverse events | Amlodipine 10mg | 1 | 276 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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/NCT00558428
GET https://conductscience.org/api/trials/v1/NCT00558428/results?page=2