Trial · NCT01134393
TElmisartan and AMlodipine Single Pill sTudy With Patients Not on Goal With Mono rAas Therapy-switch
NCT01134393, Phase 3, Completed, Boehringer Ingelheim; results first posted 2012-07-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. TElmisartan and AMlodipine Single Pill sTudy With Patients Not on Goal With Mono rAas Therapy-switch. Trials, record NCT01134393. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01134393
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TElmisartan and AMlodipine Single Pill sTudy With Patients Not on Goal With Mono rAas Therapy-switch
- NCT number
- NCT01134393
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 502 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Hypertension
- Interventions
- telmisartan/amlodipine
- First posted
- 2010-06-02
- Last updated
- 2014-01-15
- Other registries' IDs
- eudract:2009-017336-40
- Results first posted
- 2012-07-04
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements. | 12 weeks | Achieving BP control is defined as SBP\<140 mmHg and DBP\<90 mmHg. |
| Secondary | BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements. | 4 and 8 weeks | Achieving BP control is defined as SBP\<140 mmHg and DBP\<90 mmHg. |
| Secondary | BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM). | Week 12 | Achieving BP control with HBPM is defined as SBP\<135 mmHg and DBP\<85 mmHg. |
| Secondary | Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP | weeks 4, 8 and 12 | |
| Secondary | Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate | weeks 4, 8 and 12 | Pulse pressure was not analysed for this study instead pulse rate was analysed at weeks 4, 8 and 12. |
| Secondary | Change From Baseline Over Time in In-clinic Measured Mean Pulse Pressure | weeks 4, 8 and 12 | |
| Secondary | DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements | weeks 4, 8 and 12 | DBP control is defined as DBP \<90 mmHg or \<80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP \<140 mmHg or \<130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP \<90 mmHg or \<80 mmHg in patients with diabetes or renal impairment or a reduction from baseline \>=10mmHg. SBP response is defined as SBP\<140 mmHg or \<130 mmHg in patients with diabetes or renal impairment or a reduction from baseline \>=15mmHg. |
| Secondary | Percentage of Patients in Blood Pressure Categories Over Time | weeks 4, 8 and 12 | BP optimal: SBP \<120 mmHg and DBP \<80 mmHg, BP normal: SBP \<130 mmHg and DBP \<85 mmHg but not optimal, BP high-normal: SBP \<140 mmHg and DBP \<90 mmHg but not normal. Grade 1 hypertension: SBP \<160 mmHg and DBP \<100 mmHg but not high-normal, Grade 2 hypertension: SBP \<180 mmHg and DBP \<110 mmHg but not grade 1, Grade 3 hypertension: SBP \>=180 mmHg or DBP \>=110 mmHg. |
| Secondary | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | weeks 4, 8 and 12 | DBP control: DBP \<85 mmHg, SBP control: SBP \<135 mmHg, DBP response: DBP \<85 mmHg or a reduction from baseline \>=10 mmHg, SBP response: SBP \<135 mmHg or a reduction from baseline \>= 15 mmHg |
| Secondary | Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time | weeks 4 and 8 |
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 | Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements. | 12 weeks | Full Analysis Set (FAS) is defined as all patients who took at least one dose of trial medication, and for whom a baseline measurement and at least one post-baseline efficacy measurement were available. Last observation carried forward (LOCF) will be used. | Percentage of participants | NUMBER |
| SECONDARY | BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements. | 4 and 8 weeks | FAS and LOCF | Number of participants | NUMBER |
| SECONDARY | BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM). | Week 12 | FAS and LOCF and with at least one post baseline HBPM measurement | Number of participants | NUMBER |
| SECONDARY | Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP | weeks 4, 8 and 12 | FAS with non-missing data | mmHg | MEAN |
| SECONDARY | Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate | weeks 4, 8 and 12 | Treated Set (TS) with non-missing data | bpm | MEAN |
| SECONDARY | Change From Baseline Over Time in In-clinic Measured Mean Pulse Pressure | weeks 4, 8 and 12 | There was no information in the Case Report Form (CRF) | ||
| SECONDARY | DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements | weeks 4, 8 and 12 | FAS and LOCF | Number of participants | NUMBER |
| SECONDARY | Percentage of Patients in Blood Pressure Categories Over Time | weeks 4, 8 and 12 | FAS with non-missing data | Percentage of participants | NUMBER |
| SECONDARY | DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements | weeks 4, 8 and 12 | FAS and LOCF and with at least one post baseline HBPM measurement | Number of participants | NUMBER |
| SECONDARY | Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time | weeks 4 and 8 | FAS | Number of participants | NUMBER |
Source ClinicalTrials.gov
Results by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements. | T80/A5 | 67.6 | 95% Confidence Interval 63.3 to 71.7 | Percentage of participants | |
| BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements. | T80/A5 | Week 4 | 262 | Number of participants | |
| BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements. | T80/A5 | Week 8 | 330 | Number of participants | |
| BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM). | T80/A5 | Morning | 179 | Number of participants | |
| BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM). | T80/A5 | Evening | 172 | Number of participants | |
| Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP | T80/A5 | Change at week 4 SBP (N=485) | -13.58 | Standard Deviation 11.95 | mmHg |
| Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP | T80/A5 | Change at week 8 SBP (N=487) | -16.37 | Standard Deviation 12.34 | mmHg |
| Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP | T80/A5 | Change at week 12 SBP (N=487) | -16.92 | Standard Deviation 12.24 | mmHg |
| Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP | T80/A5 | Change at week 4 DBP (N=485) | -8.24 | Standard Deviation 8.77 | mmHg |
| Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP | T80/A5 | Change at week 8 DBP (N=487) | -10.33 | Standard Deviation 8.88 | mmHg |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | T80/A5 | 501 | |
| Overall Study | COMPLETED | T80/A5 | 449 | |
| Overall Study | NOT COMPLETED | T80/A5 | 52 |
Source ClinicalTrials.gov
Adverse events10
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/A5 | 26 | 501 | |
| other | Oedema peripheral | General disorders | T80/A10 | 41 | 232 | |
| serious | Duodenal ulcer | Gastrointestinal disorders | T80/A5 | 1 | 501 | |
| serious | Duodenal ulcer | Gastrointestinal disorders | T80/A10 | 0 | 232 | |
| serious | Femur fracture | Injury, poisoning and procedural complications | T80/A5 | 0 | 501 | |
| serious | Femur fracture | Injury, poisoning and procedural complications | T80/A10 | 1 | 232 | |
| serious | Fibula fracture | Injury, poisoning and procedural complications | T80/A5 | 0 | 501 | |
| serious | Fibula fracture | Injury, poisoning and procedural complications | T80/A10 | 1 | 232 | |
| serious | Upper limb fracture | Injury, poisoning and procedural complications | T80/A5 | 0 | 501 | |
| serious | Upper limb fracture | Injury, poisoning and procedural complications | T80/A10 | 1 | 232 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | T80/A5 | ||
| Total, all-cause mortality | T80/A10 | ||
| Total, other adverse events | T80/A5 | 26 | 501 |
| Total, other adverse events | T80/A10 | 41 | 232 |
| Total, serious adverse events | T80/A5 | 1 | 501 |
| Total, serious adverse events | T80/A10 | 1 | 232 |
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 |
|---|
| T80/A5 vs T80/A10: 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/NCT01134393
GET https://conductscience.org/api/trials/v1/NCT01134393/results?page=2