Trial · NCT00153101
Effectiveness and Safety of Ramipril Alone Compared With Telmisartan Alone and in Combination With Ramipril in Patients at High Risk for Cardiovascular Events. Patients Intolerant to Ramipril Were Entered in TRANSCEND, Telmisartan Compared to Placebo.
NCT00153101, Phase 4, Completed, Boehringer Ingelheim; results first posted 2009-08-25
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Effectiveness and Safety of Ramipril Alone Compared With Telmisartan Alone and in Combination With Ramipril in Patients at High Risk for Cardiovascular Events. Patients Intolerant to Ramipril Were Entered in TRANSCEND, Telmisartan Compared to Placebo. Trials, record NCT00153101. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00153101
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Effectiveness and Safety of Ramipril Alone Compared With Telmisartan Alone and in Combination With Ramipril in Patients at High Risk for Cardiovascular Events. Patients Intolerant to Ramipril Were Entered in TRANSCEND, Telmisartan Compared to Placebo.
- NCT number
- NCT00153101
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 31,546 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Cardiovascular Diseases
- Interventions
- Telmisartan, Combination of Telmisartan and Ramipril, Ramipril
- First posted
- 2005-09-12
- Last updated
- 2014-05-20
- Results first posted
- 2009-08-25
- Limitations and caveats
- Only non-serious Adverse Events (AE) which lead to discontinuation of study medication were assessed and collected; the frequency was under 5%. Non-serious AEs per se were not assessed or collected.
Source ClinicalTrials.gov
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure | 56 months | The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure. |
| Primary | ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients | 56 months | ESRD is defined by initiation of dialysis, need for renal transplantation, or eGFR \<15 mL/min/1.73 m². Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline. These renal outcomes were not adjudicated (apart from death). |
| Primary | TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure | 56 months | Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure. |
| Secondary | ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke | 56 months | The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the following defined endpoints, non-fatal myocardial infarction or non-fatal stroke |
| Secondary | ONTARGET. Cardiovascular Death | 56 months | The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint cardiovascular death. |
| Secondary | ONTARGET. Non-fatal Myocardial Infarction | 56 months | The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint non-fatal myocardial infarction. |
| Secondary | ONTARGET. Non-fatal Stroke | 56 months | The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the endpoint non-fatal stroke. |
| Secondary | ONTARGET. Hospitalization for Congestive Heart Failure | 56 months | The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint hospitalization for congestive heart failure. |
| Secondary | ONTARGET. Doubling of Serum Creatinine in Diabetic Nephropathy Patients | 56 months | Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline. |
| Secondary | ONTARGET. Progression to End Stage Renal Disease (ESRD) in Diabetic Nephropathy Patients | 56 months | ESRD is defined by initiation of dialysis, need for renal transplantation, or eGFR \<15 mL/min/1.73 m². Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline. |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 registered outcomesOutcomes38
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure | 56 months | FAS of the ONTARGET trial | participants | NUMBER |
| SECONDARY | ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke | 56 months | FAS of the ONTARGET trial | participants | NUMBER |
| SECONDARY | ONTARGET. Cardiovascular Death | 56 months | FAS of the ONTARGET trial | participants | NUMBER |
| SECONDARY | ONTARGET. Non-fatal Myocardial Infarction | 56 months | FAS of the ONTARGET trial | participants | NUMBER |
| SECONDARY | ONTARGET. Non-fatal Stroke | 56 months | FAS of the ONTARGET trial | participants | NUMBER |
| SECONDARY | ONTARGET. Hospitalization for Congestive Heart Failure | 56 months | FAS of the ONTARGET trial | participants | NUMBER |
| SECONDARY | ONTARGET. Doubling of Serum Creatinine in Diabetic Nephropathy Patients | 56 months | FAS \[DN\] of the ONTARGET trial | participants | NUMBER |
| SECONDARY | ONTARGET. Progression to End Stage Renal Disease (ESRD) in Diabetic Nephropathy Patients | 56 months | FAS \[DN\] of the ONTARGET trial | participants | NUMBER |
| SECONDARY | ONTARGET. All-cause Mortality in Diabetic Nephropathy Patients | 56 months | FAS \[DN\] of the ONTARGET trial | participants | NUMBER |
| SECONDARY | ONTARGET. Doubling of Serum Creatinine | 56 months | FAS of the ONTARGET trial | participants | NUMBER |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 outcomesResults by group97
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure | Telmisartan/Ramipril (ONTARGET) | 1386 | participants | ||
| ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure | Telmisartan (ONTARGET) | 1423 | participants | ||
| ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure | Ramipril (ONTARGET) | 1412 | participants | ||
| ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke | Telmisartan/Ramipril (ONTARGET) | 1200 | participants | ||
| ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke | Telmisartan (ONTARGET) | 1190 | participants | ||
| ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke | Ramipril (ONTARGET) | 1210 | participants | ||
| ONTARGET. Cardiovascular Death | Telmisartan/Ramipril (ONTARGET) | 620 | participants | ||
| ONTARGET. Cardiovascular Death | Telmisartan (ONTARGET) | 598 | participants | ||
| ONTARGET. Cardiovascular Death | Ramipril (ONTARGET) | 603 | participants | ||
| ONTARGET. Non-fatal Myocardial Infarction | Telmisartan/Ramipril (ONTARGET) | 424 | participants |
1 to 10 of 97Source ClinicalTrials.gov
See all 97 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Telmisartan/Ramipril (ONTARGET) | 8,502 | |
| Overall Study | STARTED | Telmisartan (ONTARGET) | 8,542 | |
| Overall Study | STARTED | Ramipril (ONTARGET) | 8,576 | |
| Overall Study | STARTED | Telmisartan (TRANSCEND) | 2,954 | |
| Overall Study | STARTED | Placebo (TRANSCEND) | 2,972 | |
| Overall Study | COMPLETED | Telmisartan/Ramipril (ONTARGET) | 8,485 | |
| Overall Study | COMPLETED | Telmisartan (ONTARGET) | 8,524 | |
| Overall Study | COMPLETED | Ramipril (ONTARGET) | 8,561 | |
| Overall Study | COMPLETED | Telmisartan (TRANSCEND) | 2,946 | |
| Overall Study | COMPLETED | Placebo (TRANSCEND) | 2,962 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events12,525
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 | Agranulocytosis | Blood and lymphatic system disorders | Telmisartan/Ramipril (ONTARGET) | 0 | 8,502 | |
| serious | Agranulocytosis | Blood and lymphatic system disorders | Telmisartan (ONTARGET) | 1 | 8,542 | |
| serious | Agranulocytosis | Blood and lymphatic system disorders | Ramipril (ONTARGET) | 0 | 8,576 | |
| serious | Agranulocytosis | Blood and lymphatic system disorders | Telmisartan (TRANSCEND) | 0 | 2,954 | |
| serious | Agranulocytosis | Blood and lymphatic system disorders | Placebo (TRANSCEND) | 0 | 2,972 | |
| serious | Anaemia | Blood and lymphatic system disorders | Telmisartan/Ramipril (ONTARGET) | 125 | 8,502 | |
| serious | Anaemia | Blood and lymphatic system disorders | Telmisartan (ONTARGET) | 156 | 8,542 | |
| serious | Anaemia | Blood and lymphatic system disorders | Ramipril (ONTARGET) | 131 | 8,576 | |
| serious | Anaemia | Blood and lymphatic system disorders | Telmisartan (TRANSCEND) | 43 | 2,954 | |
| serious | Anaemia | Blood and lymphatic system disorders | Placebo (TRANSCEND) | 36 | 2,972 |
1 to 10 of 12,525Source ClinicalTrials.gov
See all 12,525 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Telmisartan/Ramipril (ONTARGET) | ||
| Total, all-cause mortality | Telmisartan (ONTARGET) | ||
| Total, all-cause mortality | Ramipril (ONTARGET) | ||
| Total, all-cause mortality | Telmisartan (TRANSCEND) | ||
| Total, all-cause mortality | Placebo (TRANSCEND) | ||
| Total, other adverse events | Telmisartan/Ramipril (ONTARGET) | 0 | 8,502 |
| Total, other adverse events | Telmisartan (ONTARGET) | 0 | 8,542 |
| Total, other adverse events | Ramipril (ONTARGET) | 0 | 8,576 |
| Total, other adverse events | Telmisartan (TRANSCEND) | 0 | 2,954 |
| Total, other adverse events | Placebo (TRANSCEND) | 0 | 2,972 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers39
The papers the trial lists on ClinicalTrials.gov.
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 comparisons17
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Telmisartan (TRANSCEND) vs Placebo (TRANSCEND): TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke | Trial comparisons |
Telmisartan (TRANSCEND) vs Placebo (TRANSCEND): TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure | Trial comparisons |
| Telmisartan (TRANSCEND) vs Placebo (TRANSCEND): TRANSCEND. Cognitive Decline | Trial comparisons |
| Telmisartan (TRANSCEND) vs Placebo (TRANSCEND): TRANSCEND. Non-fatal Myocardial Infarction | Trial comparisons |
| Telmisartan (TRANSCEND) vs Placebo (TRANSCEND): TRANSCEND. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria | Trial comparisons |
| Telmisartan (TRANSCEND) vs Placebo (TRANSCEND): TRANSCEND. Progression to ESRD | Trial comparisons |
| Telmisartan (TRANSCEND) vs Placebo (TRANSCEND): TRANSCEND. Hospitalization for Congestive Heart Failure | Trial comparisons |
| Telmisartan (TRANSCEND) vs Placebo (TRANSCEND): TRANSCEND. Combined Endpoint of Doubling Serum Creatinine, Progression to ESRD, New Microalbuminuria or New Macroalbuminuria | Trial comparisons |
| Telmisartan (TRANSCEND) vs Placebo (TRANSCEND): TRANSCEND. Cardiovascular Death | Trial comparisons |
| Telmisartan (TRANSCEND) vs Placebo (TRANSCEND): TRANSCEND. Doubling of Serum Creatinine | Trial comparisons |
1 to 10 of 17
See all 17 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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT00153101
GET https://conductscience.org/api/trials/v1/NCT00153101/registered?page=2