Trial · NCT00926289
Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension
NCT00926289, Phase 4, Completed, Boehringer Ingelheim; results first posted 2011-05-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension. Trials, record NCT00926289. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00926289
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension
- NCT number
- NCT00926289
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 894 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Hypertension
- Interventions
- Telmisartan, Telmisartan, Hydrochlorothiazide
- First posted
- 2009-06-23
- Last updated
- 2014-06-27
- Other registries' IDs
- eudract:2008-007711-32
- Results first posted
- 2011-05-24
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7 | Baseline and Week 7 | The SBP value at baseline was subtracted from the SBP value at Week 7. |
| Secondary | Change From Baseline in Mean Seated Trough Cuff SBP to Week 5 | Baseline and Week 5 | The SBP value at baseline was subtracted from the SBP value at Week 5. |
| Secondary | Change From Baseline in Mean Seated Trough Cuff SBP to Week 3 | Baseline and Week 3 | The SBP value at baseline was subtracted from the SBP value at Week 3. |
| Secondary | Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7 | Baseline and Week 7 | The DBP value at baseline was subtracted from the DBP value at Week 7. |
| Secondary | Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7 | Week 7 timepoint | SBP control is defined as SBP \< 140 mmHg. |
| Secondary | Number of Patients With SBP Control (SBP < 140 mmHg) at Week 5 | Week 5 timepoint | SBP control is defined as SBP \< 140 mmHg |
| Secondary | Number of Patients With SBP Control (SBP < 140 mmHg) at Week 3 | Week 3 timepoint | SBP control is defined as SBP \< 140 mmHg |
| Secondary | Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7 | Week 7 timepoint | DBP control is defined as DBP\<90 mmHg |
| Secondary | Number of Patients With DBP Control (DBP < 90 mmHg) at Week 5 | Week 5 timepoint | DBP control is defined as DBP\<90 mmHg |
| Secondary | Number of Patients With DBP Control (DBP < 90 mmHg) at Week 3 | Week 3 timepoint | DBP control is defined as DBP\<90 mmHg |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
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 Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7 | Baseline and Week 7 | The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Seated Trough Cuff SBP to Week 5 | Baseline and Week 5 | The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Seated Trough Cuff SBP to Week 3 | Baseline and Week 3 | The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7 | Baseline and Week 7 | The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7 | Week 7 timepoint | The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm | Participants | NUMBER |
| SECONDARY | Number of Patients With SBP Control (SBP < 140 mmHg) at Week 5 | Week 5 timepoint | The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm | Participants | NUMBER |
| SECONDARY | Number of Patients With SBP Control (SBP < 140 mmHg) at Week 3 | Week 3 timepoint | The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm | Participants | NUMBER |
| SECONDARY | Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7 | Week 7 timepoint | The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm | Participants | NUMBER |
| SECONDARY | Number of Patients With DBP Control (DBP < 90 mmHg) at Week 5 | Week 5 timepoint | The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm | participants | NUMBER |
| SECONDARY | Number of Patients With DBP Control (DBP < 90 mmHg) at Week 3 | Week 3 timepoint | The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm | Participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group40
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 Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7 | Telmisartan 40/80 mg | -28.5 | Standard Error 0.88 | mmHg | |
| Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7 | Telmisartan 40/80 mg + HCTZ 12.5/25 mg | -37.0 | Standard Error 0.62 | mmHg | |
| Change From Baseline in Mean Seated Trough Cuff SBP to Week 5 | Telmisartan 40/80 mg | -28.6 | Standard Error 0.86 | mmHg | |
| Change From Baseline in Mean Seated Trough Cuff SBP to Week 5 | Telmisartan 40/80 mg + HCTZ 12.5/25 mg | -35.8 | Standard Error 0.61 | mmHg | |
| Change From Baseline in Mean Seated Trough Cuff SBP to Week 3 | Telmisartan 40/80 mg | -26.5 | Standard Error 0.87 | mmHg | |
| Change From Baseline in Mean Seated Trough Cuff SBP to Week 3 | Telmisartan 40/80 mg + HCTZ 12.5/25 mg | -33.3 | Standard Error 0.61 | mmHg | |
| Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7 | Telmisartan 40/80 mg | -15.4 | Standard Error 0.55 | mmHg | |
| Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7 | Telmisartan 40/80 mg + HCTZ 12.5/25 mg | -18.6 | Standard Error 0.38 | mmHg | |
| Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7 | Telmisartan 40/80 mg | 122 | Participants | ||
| Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7 | Telmisartan 40/80 mg + HCTZ 12.5/25 mg | 363 | Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 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 40/80 mg | 294 | |
| Overall Study | STARTED | Telmisartan 40/80 mg + HCTZ (Hydrochlorothiazide) 12.5/25 mg | 594 | |
| Overall Study | COMPLETED | Telmisartan 40/80 mg | 269 | |
| Overall Study | COMPLETED | Telmisartan 40/80 mg + HCTZ (Hydrochlorothiazide) 12.5/25 mg | 558 | |
| Overall Study | NOT COMPLETED | Telmisartan 40/80 mg | 25 | |
| Overall Study | NOT COMPLETED | Telmisartan 40/80 mg + HCTZ (Hydrochlorothiazide) 12.5/25 mg | 36 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| serious | Epilepsy | Nervous system disorders | Telmisartan 40/80 mg | 1 | 294 | |
| serious | Epilepsy | Nervous system disorders | Telmisartan 40/80 mg + HCTZ 12.5/25 mg | 0 | 594 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Telmisartan 40/80 mg | ||
| Total, all-cause mortality | Telmisartan 40/80 mg + HCTZ 12.5/25 mg | ||
| Total, other adverse events | Telmisartan 40/80 mg | 0 | 294 |
| Total, other adverse events | Telmisartan 40/80 mg + HCTZ 12.5/25 mg | 0 | 594 |
| Total, serious adverse events | Telmisartan 40/80 mg | 1 | 294 |
| Total, serious adverse events | Telmisartan 40/80 mg + HCTZ 12.5/25 mg | 0 | 594 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22717420 | DERIVED |
Source PubMed
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 comparisons11
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Telmisartan 40/80 mg vs Telmisartan 40/80 mg + HCTZ 12.5/25 mg: Number of Patients With SBP Control (SBP < 140 mmHg) at Week 5 | Trial comparisons |
| Telmisartan 40/80 mg vs Telmisartan 40/80 mg + HCTZ 12.5/25 mg: Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7 | Trial comparisons |
| Telmisartan 40/80 mg vs Telmisartan 40/80 mg + HCTZ 12.5/25 mg: Number of Participants With DBP Response at Week 7 | Trial comparisons |
| Telmisartan 40/80 mg vs Telmisartan 40/80 mg + HCTZ 12.5/25 mg: Number of Patients With Systolic Blood Pressure (SBP) Response at Week 7 | Trial comparisons |
| Telmisartan 40/80 mg vs Telmisartan 40/80 mg + HCTZ 12.5/25 mg: Number of Patients With DBP Control (DBP < 90 mmHg) at Week 3 | Trial comparisons |
| Telmisartan 40/80 mg vs Telmisartan 40/80 mg + HCTZ 12.5/25 mg: Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7 | Trial comparisons |
| Telmisartan 40/80 mg vs Telmisartan 40/80 mg + HCTZ 12.5/25 mg: Number of Patients With SBP Control (SBP < 140 mmHg) at Week 3 | Trial comparisons |
| Telmisartan 40/80 mg vs Telmisartan 40/80 mg + HCTZ 12.5/25 mg: Number of Patients With BP Control at Week 7 | Trial comparisons |
| Telmisartan 40/80 mg vs Telmisartan 40/80 mg + HCTZ 12.5/25 mg: Number of Patients With DBP Control (DBP < 90 mmHg) at Week 5 | Trial comparisons |
| Telmisartan 40/80 mg vs Telmisartan 40/80 mg + HCTZ 12.5/25 mg: Number of Patients With Blood Pressure (BP) Control at Week 7 | Trial comparisons |
1 to 10 of 11
See all 11 trial comparisonsTests0
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/NCT00926289
GET https://conductscience.org/api/trials/v1/NCT00926289/results?page=2