Trial · NCT00558064
Filtered Trial for Amlodipine Non-responder
NCT00558064, Phase 3, Completed, Boehringer Ingelheim; results first posted 2010-02-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Filtered Trial for Amlodipine Non-responder. Trials, record NCT00558064. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00558064
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Filtered Trial for Amlodipine Non-responder
- NCT number
- NCT00558064
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 531 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Hypertension
- Interventions
- telmisartan+amlodipine, amlodipine
- First posted
- 2007-11-14
- Last updated
- 2014-07-08
- Results first posted
- 2010-02-01
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing) | Baseline and 8 Weeks | The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline. |
| Secondary | Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing) | Baseline and 8 Weeks | The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline. |
| Secondary | Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline) | 8 weeks | Seated trough diastolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake |
| Secondary | Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline) | 8 weeks | Seated trough systolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake |
| Secondary | Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline) | 8 weeks | Adequate response defined that seated trough diastolic blood pressure was \<90 mmHg or decreased from reference baseline by \>=10 mmHg at 8 weeks |
| Secondary | Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks | 8 weeks | Adequate response defined that seated trough systolic blood pressure was \<140 mmHg or decreased from reference baseline by \>=20 mmHg at 8 weeks (0 percent at baseline) |
| Secondary | Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline) | 8 weeks | Optimal, normal, high normal blood pressure were defined as follows: * Optimal: Systolic blood pressure (SBP) \< 120 mmHg and diastolic blood pressure (DBP) \< 80 mmHg * Normal: SBP \>= 120 mmHg or DBP \>= 80 mmHg and SBP \< 130 mmHg and DBP \< 85 mmHg * High normal: SBP \>= 130 mmHg or DBP \>= 85 mmHg and SBP \< 140 mmHg and DBP \< 90 mmHg * No: SBP \>= 140 mmHg and DPB \>= 90 mmHg |
| Secondary | Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG | First administration of randomised treatment to 24 hours post last dose of randomised treatment | Clinical relevant abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. |
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 | Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing) | Baseline and 8 Weeks | Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose. | mmHg | MEAN |
| SECONDARY | Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing) | Baseline and 8 Weeks | Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose. | mmHg | MEAN |
| SECONDARY | Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline) | 8 weeks | Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline) | 8 weeks | Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline) | 8 weeks | Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks | 8 weeks | Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline) | 8 weeks | Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after the start of the double-blind maintenance period on final dose. | percentage of patients | NUMBER |
| SECONDARY | Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG | First administration of randomised treatment to 24 hours post last dose of randomised treatment | Treated set: Patients randomised to the double-blind treatment period who took at least one dose either of T40+A5 or A5 during the double-blind treatment period. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing) | Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination | 9.56 | Standard Error 0.61 | mmHg | |
| Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing) | Amlodipine 5 mg Monotherapy | 4.45 | Standard Error 0.61 | mmHg | |
| Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing) | Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination | 13.04 | Standard Error 0.88 | mmHg | |
| Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing) | Amlodipine 5 mg Monotherapy | 5.77 | Standard Error 0.88 | mmHg | |
| Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline) | Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination | 68.1 | percentage of patients | ||
| Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline) | Amlodipine 5 mg Monotherapy | 47.1 | percentage of patients | ||
| Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline) | Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination | 67.1 | percentage of patients | ||
| Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline) | Amlodipine 5 mg Monotherapy | 45.8 | percentage of patients | ||
| Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline) | Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination | 74.5 | percentage of patients | ||
| Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline) | Amlodipine 5 mg Monotherapy | 50.2 | percentage of patients |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination | 269 | |
| Overall Study | STARTED | Amlodipine 5 mg Monotherapy | 262 | |
| Overall Study | COMPLETED | Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination | 264 | |
| Overall Study | COMPLETED | Amlodipine 5 mg Monotherapy | 257 | |
| Overall Study | NOT COMPLETED | Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination | 5 | |
| Overall Study | NOT COMPLETED | Amlodipine 5 mg Monotherapy | 5 |
Source ClinicalTrials.gov
Adverse events8
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 | Nasopharyngitis | Infections and infestations | Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination | 25 | 269 | |
| other | Nasopharyngitis | Infections and infestations | Amlodipine 5 mg Monotherapy | 34 | 262 | |
| serious | Guillain-Barre syndrome | Nervous system disorders | Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination | 1 | 269 | |
| serious | Guillain-Barre syndrome | Nervous system disorders | Amlodipine 5 mg Monotherapy | 0 | 262 | |
| serious | Angina pectoris | Cardiac disorders | Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination | 0 | 269 | |
| serious | Angina pectoris | Cardiac disorders | Amlodipine 5 mg Monotherapy | 1 | 262 | |
| serious | Cerebellar infarction | Nervous system disorders | Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination | 0 | 269 | |
| serious | Cerebellar infarction | Nervous system disorders | Amlodipine 5 mg Monotherapy | 1 | 262 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination | ||
| Total, all-cause mortality | Amlodipine 5 mg Monotherapy | ||
| Total, other adverse events | Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination | 25 | 269 |
| Total, other adverse events | Amlodipine 5 mg Monotherapy | 34 | 262 |
| Total, serious adverse events | Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination | 1 | 269 |
| Total, serious adverse events | Amlodipine 5 mg Monotherapy | 2 | 262 |
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 |
|---|
| Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination vs Amlodipine 5 mg Monotherapy: 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/NCT00558064
GET https://conductscience.org/api/trials/v1/NCT00558064/results?page=2