Cardiovascular Diseases
Conditions
Brief summary
The Ongoing Telmisartan Alone and in combination wiht Ramipril Global Endpoint trial (ONTARGET): The primary objectives are to determine if (a) telmisartan 80mg daily and ramipril 10mg daily combination therapy is more effective in reducing the composite endpoint of Cardiovascular Death (CV) death, Myocardial infarction (MI), stroke or hospitalization for Congestive Heart Failure (CHF) compared with ramipril 10mg alone; and (b) telmisartan 80mg daily is at least as effective as (i.e. not less effective than) ramipril 10mg daily, on this endpoint. Telmisartan Randomised Assessment Study in Angiotension converting Enzyme inhibitor intolerant subjects with Cardiovascular Disease. (TRANSCEND): The primary objective of the study is to determine if treatment with telmisartan 80mg daily is superior to placebo reducing the composite endpoint of Cardiovascular Death (CV), Myocardial Infarction ( MI)I, stroke or hospitalization for Congestive Heart Failure (CHF) in patients who are intolerant to Angiotension Converting Enzyme inhibitors.
Interventions
DRUGCombination of Telmisartan and Ramipril
DRUGRamipril
DRUGTelmisartan
Sponsors
Boehringer Ingelheim
Study design
Intervention model
PARALLEL
Primary purpose
PREVENTION
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Coronary Artery Disease: Previous Myocardial infarction(\> 2 days prior to informed consent), or stable or previous unstable angina (\> 30 days prior to informed consent) with documented multivessel coronary artery disease or a positive stress test, or multivessel Percutaneous Transluminal Coronary Angioplasty (\> 30 days prior to informed consent), or previous multivessel Coronary Artery Bypass Grafting without angina (if surgery performed \> 4 years prior to informed consent) or with recurrent angina after surgery. Other High Risk: 1. Peripheral Arterial Disease: Previous limb bypass surgery or angioplasty or amputation, intermittent claudication on history with ankle/arm Blood Pressure ratio \< 0.8 on at least one side, or significant stenosis by angiography or non-invasive testing 2. Previous stroke 3. Transient ischemic Attack \> 7 days and \< 1 year prior to informed consent 4. Diabetes Mellitus (types I or II): with evidence of end-organ damage (retinopathy, Left ventricular hypertrophy, micro or macro albuminuria), or any evidence of previous cardiac or vascular disease. No definite and specific indication or contraindication for any of the study treatments. Written informed consent.
Exclusion criteria
A. Medication use: 1. Inability to discontinue Angiotension Converting Enzyme (ACE) inhibitors or Angiotension 2 receptor antagonists (AIIAs). 2. Patients with known hypersensitivity or intolerance to Angiotension 2 receptor antagonists (AIIAs) or Angiotension Converting Enzyme (ACE)inhibitors. NOTE: Patients with known intolerance to Angiotension Converting Enzyme inhibitor intolerance ( ACE-I) can be enrolled in the TRANSCEND study. B. Cardiovascular disease: 1. Symptomatic congestive heart failure. 2. Hemodynamically significant primary valvular or outflow tract obstruction (e.g. aortic or mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve). 3. Constrictive pericarditis. 4. Complex congenital heart disease. 5. Syncopal episodes of unknown etiology \< 3 months before informed consent. 6. Planned cardiac surgery or angioplasty within three months. 7. Uncontrolled hypertension on treatment (i.e.Blood pressure ( BP) \> 160/100). 8. Heart transplant recipient. 9. Strokes due to subarachnoid hemorrhage C. Other conditions: 1. Significant renal disease defined as: 1. Renal artery stenosis; 2. Creatinine clearance \< 0.6 ml/min or serum creatinine \> 265 umol/L (\> 3.0 mg/dL); 3. Hyperkalemia: potassium \> 5.5 mmol/L. 4. Proteinuria\* (for TRANSCEND only). 2. Hepatic dysfunction as defined by the following laboratory parameters: Serum Glutamate Pyruvate Transaminase( SGPT) Alaninaminotransferase (ALT) or Serum Glutamic Oxaloacetic Transaminase (SGOT) Aspartate aminotransferase (AST) \> than 4 times upper limit of normal or additional criteria for hepatic impairment the upper limit of normal range, total Bilirubin \> 20 umol/L, biliary obstructive disorders. 3. Uncorrected volume depletion or sodium depletion. 4. Primary aldosteronism. 5. Hereditary fructose intolerance. 6. Any other major non-cardiac illness expected to reduce life expectancy or interfere with study participation. 7. Patient is simultaneously taking another experimental drug. 8. Patient with significant disability that precludes regular attendance at clinic for follow-up. 9. Patient has sufficient disability or other incapacity that precludes regular attendance at clinic for follow-up. 10. Unable or unwilling to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| ONTARGET. All-cause Mortality 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. |
| ONTARGET. Doubling of Serum Creatinine | 56 months | ONTARGET. Nephropathy subcategory: doubling of serum creatinine |
| ONTARGET. Progression to ESRD | 56 months | ONTARGET. Nephropathy subcategory: Progression to ESRD. Progression to ESRD is defined as initiation of dialysis, need for renal transplantation, or eGFR \<15 mL/min/1.73 m². |
| ONTARGET. New Microalbuminuria | 56 months | ONTARGET. Nephropathy subcategory: New microalbuminuria. New microalbuminuria is defined as Urinary Albumin Creatinine Ratio ≥30 mg/g Crea in patients with a Urinary Albumin Creatinine Ratio \<30 mg/g Crea at baseline. |
| ONTARGET. New Macroalbuminuria | 56 months | ONTARGET. Nephropathy subcategory: New macroalbuminuria. New macroalbuminuria is defined as Urinary Albumin Creatinine Ratio ≥300 mg/g Crea in patients with a Urinary Albumin Creatinine Ratio \<300 mg/g Crea at baseline. |
| ONTARGET. Combined Endpoint of Doubling of Serum Creatinine, Progression to ESRD, New Microalbuminuria, or New Macroalbuminuria | 56 months | ONTARGET. Nephropathy subcategory: Combined endpoint of doubling of serum creatinine, progression to ESRD, new microalbuminuria, or new macroalbuminuria |
| ONTARGET. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria | 56 months | ONTARGET. Nephropathy subcategory: Normalisation from micro- or macroalbuminuria to normoalbuminuria. Normalisation from micro- or macroalbuminuria to normoalbuminuria is defined as UACR \<30 mg/g Crea in patients with a UACR ≥30 mg/g Crea at baseline. |
| ONTARGET. Newly Diagnosed 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 Newly diagnosed Congestive Heart failure. |
| ONTARGET. Cardiovascular Revascularization Procedure | 56 months | The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). |
| ONTARGET. Newly Diagnosed Diabetes | 56 months | The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint Newly diagnosed Diabetes. Only calculated for those patients without diabetes at baseline. |
| ONTARGET. Cognitive Decline | 56 months | The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the endpoint cognitive decline i.e. Comparison of the Mini mental state Evaluation (MMSE) of patients at baseline with that at the 2years and end of trial. A decrease in MMSE from baseline represents a cognitive decline. This outcome measure is only available for those patients who had MMSE at baseline. |
| ONTARGET. New Onset of Atrial Fibrillation | 56 months | The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of endpoint new onset of atrial fibrillation. |
| 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 |
| TRANSCEND. Cardiovascular Death | 56 months | Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint cardiovascular death. |
| TRANSCEND. Non-fatal Myocardial Infarction | 56 months | Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint non-fatal myocardial infarction. |
| TRANSCEND. Non-fatal Stroke | 56 months | Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). |
| TRANSCEND. Hospitalization for Congestive Heart Failure | 56 months | Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). |
| TRANSCEND. Doubling of Serum Creatinine | 56 months | TRANSCEND. Nephropathy subcategory: doubling of serum creatinine |
| TRANSCEND. Progression to ESRD | 56 months | TRANSCEND. Nephropathy subcategory: Progression to ESRD. Progression to ESRD is defined as initiation of dialysis, need for renal transplantation, or eGFR \<15 mL/min/1.73m² |
| TRANSCEND. New Microalbuminuria | 56 months | TRANSCEND. Nephropathy subcategory: New microalbuminuria. New microalbuminuria is defined as UACR ≥30 mg/g creatinine \[Crea\] in patients with a UACR \<30 mg/g Crea at baseline |
| TRANSCEND. New Macroalbuminuria | 56 months | TRANSCEND. Nephropathy subcategory: New macroalbuminuria. New macroalbuminuria is defined as UACR ≥300 mg/g creatinine \[Crea\] in patients with a UACR \<300 mg/g Crea at baseline |
| TRANSCEND. Combined Endpoint of Doubling Serum Creatinine, Progression to ESRD, New Microalbuminuria or New Macroalbuminuria | 56 months | TRANSCEND. Nephropathy subcategory: Combined endpoint of doubling serum creatinine, progression to ESRD, new microalbuminuria or new macroalbuminuria |
| TRANSCEND. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria | 56 months | TRANSCEND. Nephropathy subcategory: Normalisation from micro- or macroalbuminuria to normoalbuminuria. Normalisation from micro- or macroalbuminuria to normoalbuminuria is defined as UACR \<30 mg/g Crea in patients with a UACR ≥30 mg/g Crea at baseline. |
| TRANSCEND. New Onset of Atrial Fibrillation | 56 months | Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). |
| TRANSCEND. Cognitive Decline | 56 months | Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the endpoint cognitive decline i.e. Comparison of the Mini mental state Evaluation (MMSE) of patients at baseline with that at the 2years and end of trial. A decrease in MMSE from baseline represents a cognitive decline. This outcome measure is only available for those patients who had MMSE at baseline. |
| TRANSCEND. Newly Diagnosed Diabetes | 56 months | Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint Newly diagnosed Diabetes. Only calculated for those patients without diabetes at baseline. |
| TRANSCEND. Cardiovascular Revascularization Procedure | 56 months | Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). |
| TRANSCEND. Newly Diagnosed Congestive Heart Failure | 56 months | Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). |
| TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke | 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. |
| 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. |
| 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. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Puerto Rico, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Arab Emirates, United Kingdom, United States
Participant flow
Recruitment details
At the randomization visit, patients who have adhered to the medication regimen (consumed \> 75% of ramipril + telmisartan during run-in phase) and were Angiotensin Converting Enzyme (ACE) tolerant were randomized into the main study (ONTARGET). ACE intolerant patients were randomized into the parallel trial (TRANSCEND).
Participants by arm
| Arm | Count |
|---|---|
| Telmisartan/Ramipril (ONTARGET) Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning. | 8,502 |
| Telmisartan (ONTARGET) Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning. | 8,542 |
| Ramipril (ONTARGET) Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning. | 8,576 |
| Telmisartan (TRANSCEND) Telmisartan 80mg tablet, one tablet administered once daily in the morning. | 2,954 |
| Placebo (TRANSCEND) Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning. | 2,972 |
| Total | 31,546 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 14 | 14 | 12 | 5 | 5 |
| Overall Study | Withdrawal by Subject | 3 | 4 | 3 | 3 | 5 |
Baseline characteristics
| Characteristic | Telmisartan/Ramipril (ONTARGET) | Telmisartan (ONTARGET) | Ramipril (ONTARGET) | Telmisartan (TRANSCEND) | Placebo (TRANSCEND) | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 66.4 years STANDARD_DEVIATION 7.3 | 66.4 years STANDARD_DEVIATION 7.1 | 66.4 years STANDARD_DEVIATION 7.2 | 66.9 years STANDARD_DEVIATION 7.3 | 66.9 years STANDARD_DEVIATION 7.4 | 66.5 years STANDARD_DEVIATION 7.2 |
| Sex: Female, Male Female | 2250 Participants | 2250 Participants | 2331 Participants | 1280 Participants | 1267 Participants | 9378 Participants |
| Sex: Female, Male Male | 6252 Participants | 6292 Participants | 6245 Participants | 1674 Participants | 1705 Participants | 22168 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 8,502 | 0 / 8,542 | 0 / 8,576 | 0 / 2,954 | 0 / 2,972 |
| serious Total, serious adverse events | 5,268 / 8,502 | 5,506 / 8,542 | 5,375 / 8,576 | 1,781 / 2,954 | 1,830 / 2,972 |
Outcome results
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
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).
Time frame: 56 months
Population: Subset of the Full Analysis Set (FAS \[DN\]) consisting of all randomised patients with diabetic nephropathy (UACR ≥300 mg/g Crea) of the ONTARGET trial.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | 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 | 108 participants |
| Telmisartan (ONTARGET) | 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 | 119 participants |
| Ramipril (ONTARGET) | 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 | 112 participants |
p-value: 0.546195% CI: [0.71, 1.2]Regression, Cox
p-value: 0.343695% CI: [0.68, 1.14]Regression, Cox
Primary
ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure
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.
Time frame: 56 months
Population: FAS of the ONTARGET trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure | 1386 participants |
| Telmisartan (ONTARGET) | ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure | 1423 participants |
| Ramipril (ONTARGET) | ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure | 1412 participants |
p-value: 0.846295% CI: [0.92, 1.07]Regression, Cox
p-value: 0.001997.5% CI: [0.93, 1.1]Regression, Cox
Primary
TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure
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.
Time frame: 56 months
Population: FAS of the TRANSCEND trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure | 465 participants |
| Telmisartan (ONTARGET) | TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure | 504 participants |
p-value: 0.219295% CI: [0.81, 1.05]Regression, Cox
Secondary
ONTARGET. All-cause Mortality in Diabetic Nephropathy Patients
Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.
Time frame: 56 months
Population: FAS \[DN\] of the ONTARGET trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | ONTARGET. All-cause Mortality in Diabetic Nephropathy Patients | 75 participants |
| Telmisartan (ONTARGET) | ONTARGET. All-cause Mortality in Diabetic Nephropathy Patients | 92 participants |
| Ramipril (ONTARGET) | ONTARGET. All-cause Mortality in Diabetic Nephropathy Patients | 83 participants |
p-value: 0.368295% CI: [0.63, 1.18]Regression, Cox
p-value: 0.601495% CI: [0.69, 1.24]Regression, Cox
Secondary
ONTARGET. Cardiovascular Death
The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint cardiovascular death.
Time frame: 56 months
Population: FAS of the ONTARGET trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | ONTARGET. Cardiovascular Death | 620 participants |
| Telmisartan (ONTARGET) | ONTARGET. Cardiovascular Death | 598 participants |
| Ramipril (ONTARGET) | ONTARGET. Cardiovascular Death | 603 participants |
p-value: 0.453595% CI: [0.93, 1.17]Regression, Cox
p-value: 0.942195% CI: [0.89, 1.12]Regression, Cox
Secondary
ONTARGET. Cardiovascular Revascularization Procedure
The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET).
Time frame: 56 months
Population: FAS of the ONTARGET trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | ONTARGET. Cardiovascular Revascularization Procedure | 1303 participants |
| Telmisartan (ONTARGET) | ONTARGET. Cardiovascular Revascularization Procedure | 1290 participants |
| Ramipril (ONTARGET) | ONTARGET. Cardiovascular Revascularization Procedure | 1269 participants |
p-value: 0.271395% CI: [0.97, 1.13]Regression, Cox
p-value: 0.51595% CI: [0.95, 1.11]Regression, Cox
Secondary
ONTARGET. Cognitive Decline
The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the endpoint cognitive decline i.e. Comparison of the Mini mental state Evaluation (MMSE) of patients at baseline with that at the 2years and end of trial. A decrease in MMSE from baseline represents a cognitive decline. This outcome measure is only available for those patients who had MMSE at baseline.
Time frame: 56 months
Population: Only patients of the ONTARGET trial treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months with Mini mental state evaluation (MMSE) at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | ONTARGET. Cognitive Decline | 561 participants |
| Telmisartan (ONTARGET) | ONTARGET. Cognitive Decline | 600 participants |
| Ramipril (ONTARGET) | ONTARGET. Cognitive Decline | 577 participants |
Comparison: for subjects with available Mini Mental State Examination (MMSE) at baselinep-value: 0.86995% CI: [0.89, 1.11]Chi-squared
Comparison: for subjects with available Mini Mental State Examination (MMSE) at baselinep-value: 0.433795% CI: [0.94, 1.17]Chi-squared
Secondary
ONTARGET. Combined Endpoint of Doubling of Serum Creatinine, Progression to ESRD, New Microalbuminuria, or New Macroalbuminuria
ONTARGET. Nephropathy subcategory: Combined endpoint of doubling of serum creatinine, progression to ESRD, new microalbuminuria, or new macroalbuminuria
Time frame: 56 months
Population: FAS of the ONTARGET trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | ONTARGET. Combined Endpoint of Doubling of Serum Creatinine, Progression to ESRD, New Microalbuminuria, or New Macroalbuminuria | 1067 participants |
| Telmisartan (ONTARGET) | ONTARGET. Combined Endpoint of Doubling of Serum Creatinine, Progression to ESRD, New Microalbuminuria, or New Macroalbuminuria | 1101 participants |
| Ramipril (ONTARGET) | ONTARGET. Combined Endpoint of Doubling of Serum Creatinine, Progression to ESRD, New Microalbuminuria, or New Macroalbuminuria | 1190 participants |
p-value: 0.011195% CI: [0.83, 0.98]Regression, Cox
p-value: 0.060695% CI: [0.85, 1]Regression, Cox
Secondary
ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
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
Time frame: 56 months
Population: FAS of the ONTARGET trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke | 1200 participants |
| Telmisartan (ONTARGET) | ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke | 1190 participants |
| Ramipril (ONTARGET) | ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke | 1210 participants |
p-value: 0.908695% CI: [0.93, 1.09]Regression, Cox
p-value: 0.000497.5% CI: [0.9, 1.08]Regression, Cox
Secondary
ONTARGET. Doubling of Serum Creatinine
ONTARGET. Nephropathy subcategory: doubling of serum creatinine
Time frame: 56 months
Population: FAS of the ONTARGET trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | ONTARGET. Doubling of Serum Creatinine | 167 participants |
| Telmisartan (ONTARGET) | ONTARGET. Doubling of Serum Creatinine | 160 participants |
| Ramipril (ONTARGET) | ONTARGET. Doubling of Serum Creatinine | 149 participants |
p-value: 0.25595% CI: [0.91, 1.42]Regression, Cox
p-value: 0.529795% CI: [0.86, 1.34]Regression, Cox
Secondary
ONTARGET. Doubling of Serum Creatinine in Diabetic Nephropathy Patients
Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline.
Time frame: 56 months
Population: FAS \[DN\] of the ONTARGET trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | ONTARGET. Doubling of Serum Creatinine in Diabetic Nephropathy Patients | 30 participants |
| Telmisartan (ONTARGET) | ONTARGET. Doubling of Serum Creatinine in Diabetic Nephropathy Patients | 24 participants |
| Ramipril (ONTARGET) | ONTARGET. Doubling of Serum Creatinine in Diabetic Nephropathy Patients | 23 participants |
p-value: 0.422195% CI: [0.73, 2.15]Regression, Cox
p-value: 0.730595% CI: [0.51, 1.6]Regression, Cox
Secondary
ONTARGET. Hospitalization for Congestive Heart Failure
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.
Time frame: 56 months
Population: FAS of the ONTARGET trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | ONTARGET. Hospitalization for Congestive Heart Failure | 332 participants |
| Telmisartan (ONTARGET) | ONTARGET. Hospitalization for Congestive Heart Failure | 394 participants |
| Ramipril (ONTARGET) | ONTARGET. Hospitalization for Congestive Heart Failure | 354 participants |
p-value: 0.498495% CI: [0.82, 1.1]Regression, Cox
p-value: 0.120395% CI: [0.97, 1.29]Regression, Cox
Secondary
ONTARGET. Newly Diagnosed Congestive Heart Failure
The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint Newly diagnosed Congestive Heart failure.
Time frame: 56 months
Population: FAS of the ONTARGET trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | ONTARGET. Newly Diagnosed Congestive Heart Failure | 469 participants |
| Telmisartan (ONTARGET) | ONTARGET. Newly Diagnosed Congestive Heart Failure | 529 participants |
| Ramipril (ONTARGET) | ONTARGET. Newly Diagnosed Congestive Heart Failure | 503 participants |
p-value: 0.373295% CI: [0.83, 1.07]Regression, Cox
p-value: 0.363395% CI: [0.94, 1.2]Regression, Cox
Secondary
ONTARGET. Newly Diagnosed Diabetes
The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint Newly diagnosed Diabetes. Only calculated for those patients without diabetes at baseline.
Time frame: 56 months
Population: Only patients of the ONTARGET trial treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months without baseline diabetes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | ONTARGET. Newly Diagnosed Diabetes | 224 participants |
| Telmisartan (ONTARGET) | ONTARGET. Newly Diagnosed Diabetes | 277 participants |
| Ramipril (ONTARGET) | ONTARGET. Newly Diagnosed Diabetes | 249 participants |
Comparison: for subjects without diabetes at baselinep-value: 0.348595% CI: [0.77, 1.1]Regression, Cox
Comparison: for subjects without diabetes at baselinep-value: 0.123595% CI: [0.96, 1.36]Regression, Cox
Secondary
ONTARGET. New Macroalbuminuria
ONTARGET. Nephropathy subcategory: New macroalbuminuria. New macroalbuminuria is defined as Urinary Albumin Creatinine Ratio ≥300 mg/g Crea in patients with a Urinary Albumin Creatinine Ratio \<300 mg/g Crea at baseline.
Time frame: 56 months
Population: FAS of the ONTARGET trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | ONTARGET. New Macroalbuminuria | 205 participants |
| Telmisartan (ONTARGET) | ONTARGET. New Macroalbuminuria | 229 participants |
| Ramipril (ONTARGET) | ONTARGET. New Macroalbuminuria | 257 participants |
p-value: 0.021395% CI: [0.67, 0.97]Regression, Cox
p-value: 0.239695% CI: [0.75, 1.07]Regression, Cox
Secondary
ONTARGET. New Microalbuminuria
ONTARGET. Nephropathy subcategory: New microalbuminuria. New microalbuminuria is defined as Urinary Albumin Creatinine Ratio ≥30 mg/g Crea in patients with a Urinary Albumin Creatinine Ratio \<30 mg/g Crea at baseline.
Time frame: 56 months
Population: FAS of the ONTARGET trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | ONTARGET. New Microalbuminuria | 763 participants |
| Telmisartan (ONTARGET) | ONTARGET. New Microalbuminuria | 799 participants |
| Ramipril (ONTARGET) | ONTARGET. New Microalbuminuria | 869 participants |
p-value: 0.013395% CI: [0.8, 0.97]Regression, Cox
p-value: 0.125195% CI: [0.84, 1.02]Regression, Cox
Secondary
ONTARGET. New Onset of Atrial Fibrillation
The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of endpoint new onset of atrial fibrillation.
Time frame: 56 months
Population: Only patients of the ONTARGET trial treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months without atrial fibrillation at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | ONTARGET. New Onset of Atrial Fibrillation | 542 participants |
| Telmisartan (ONTARGET) | ONTARGET. New Onset of Atrial Fibrillation | 560 participants |
| Ramipril (ONTARGET) | ONTARGET. New Onset of Atrial Fibrillation | 586 participants |
Comparison: for subjects without atrial fibrillation at baselinep-value: 0.266695% CI: [0.83, 1.05]Regression, Cox
Comparison: for subjects without atrial fibrillation at baselinep-value: 0.478495% CI: [0.85, 1.08]Regression, Cox
Secondary
ONTARGET. Non-fatal Myocardial Infarction
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.
Time frame: 56 months
Population: FAS of the ONTARGET trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | ONTARGET. Non-fatal Myocardial Infarction | 424 participants |
| Telmisartan (ONTARGET) | ONTARGET. Non-fatal Myocardial Infarction | 431 participants |
| Ramipril (ONTARGET) | ONTARGET. Non-fatal Myocardial Infarction | 400 participants |
p-value: 0.290995% CI: [0.94, 1.23]Regression, Cox
p-value: 0.253495% CI: [0.94, 1.24]Regression, Cox
Secondary
ONTARGET. Non-fatal Stroke
The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the endpoint non-fatal stroke.
Time frame: 56 months
Population: FAS of the ONTARGET trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | ONTARGET. Non-fatal Stroke | 364 participants |
| Telmisartan (ONTARGET) | ONTARGET. Non-fatal Stroke | 364 participants |
| Ramipril (ONTARGET) | ONTARGET. Non-fatal Stroke | 402 participants |
p-value: 0.224895% CI: [0.79, 1.06]Regression, Cox
p-value: 0.182995% CI: [0.79, 1.05]Regression, Cox
Secondary
ONTARGET. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria
ONTARGET. Nephropathy subcategory: Normalisation from micro- or macroalbuminuria to normoalbuminuria. Normalisation from micro- or macroalbuminuria to normoalbuminuria is defined as UACR \<30 mg/g Crea in patients with a UACR ≥30 mg/g Crea at baseline.
Time frame: 56 months
Population: FAS of the ONTARGET trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | ONTARGET. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria | 508 participants |
| Telmisartan (ONTARGET) | ONTARGET. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria | 483 participants |
| Ramipril (ONTARGET) | ONTARGET. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria | 448 participants |
p-value: 0.008295% CI: [1.05, 1.35]Regression, Cox
p-value: 0.216495% CI: [0.95, 1.23]Regression, Cox
Secondary
ONTARGET. Progression to End Stage Renal Disease (ESRD) in Diabetic Nephropathy Patients
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.
Time frame: 56 months
Population: FAS \[DN\] of the ONTARGET trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | ONTARGET. Progression to End Stage Renal Disease (ESRD) in Diabetic Nephropathy Patients | 30 participants |
| Telmisartan (ONTARGET) | ONTARGET. Progression to End Stage Renal Disease (ESRD) in Diabetic Nephropathy Patients | 24 participants |
| Ramipril (ONTARGET) | ONTARGET. Progression to End Stage Renal Disease (ESRD) in Diabetic Nephropathy Patients | 32 participants |
p-value: 0.624895% CI: [0.54, 1.45]Regression, Cox
p-value: 0.075195% CI: [0.36, 1.05]Regression, Cox
Secondary
ONTARGET. Progression to ESRD
ONTARGET. Nephropathy subcategory: Progression to ESRD. Progression to ESRD is defined as initiation of dialysis, need for renal transplantation, or eGFR \<15 mL/min/1.73 m².
Time frame: 56 months
Population: FAS of the ONTARGET trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | ONTARGET. Progression to ESRD | 79 participants |
| Telmisartan (ONTARGET) | ONTARGET. Progression to ESRD | 67 participants |
| Ramipril (ONTARGET) | ONTARGET. Progression to ESRD | 71 participants |
p-value: 0.459395% CI: [0.82, 1.56]Regression, Cox
p-value: 0.746895% CI: [0.68, 1.32]Regression, Cox
Secondary
TRANSCEND. Cardiovascular Death
Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint cardiovascular death.
Time frame: 56 months
Population: FAS of the TRANSCEND trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | TRANSCEND. Cardiovascular Death | 227 participants |
| Telmisartan (ONTARGET) | TRANSCEND. Cardiovascular Death | 223 participants |
p-value: 0.776495% CI: [0.85, 1.24]Regression, Cox
Secondary
TRANSCEND. Cardiovascular Revascularization Procedure
Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).
Time frame: 56 months
Population: FAS of the TRANSCEND trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | TRANSCEND. Cardiovascular Revascularization Procedure | 351 participants |
| Telmisartan (ONTARGET) | TRANSCEND. Cardiovascular Revascularization Procedure | 390 participants |
p-value: 0.143195% CI: [0.78, 1.04]Regression, Cox
Secondary
TRANSCEND. Cognitive Decline
Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the endpoint cognitive decline i.e. Comparison of the Mini mental state Evaluation (MMSE) of patients at baseline with that at the 2years and end of trial. A decrease in MMSE from baseline represents a cognitive decline. This outcome measure is only available for those patients who had MMSE at baseline.
Time frame: 56 months
Population: Only patients of the TRANSCEND trial treated with Telmisartan 80mg or telmisartan 80mg placebo daily for 56 months with Mini mental state evaluation (MMSE) at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | TRANSCEND. Cognitive Decline | 230 participants |
| Telmisartan (ONTARGET) | TRANSCEND. Cognitive Decline | 192 participants |
p-value: 0.086895% CI: [0.98, 1.41]Chi-squared
Secondary
TRANSCEND. Combined Endpoint of Doubling Serum Creatinine, Progression to ESRD, New Microalbuminuria or New Macroalbuminuria
TRANSCEND. Nephropathy subcategory: Combined endpoint of doubling serum creatinine, progression to ESRD, new microalbuminuria or new macroalbuminuria
Time frame: 56 months
Population: FAS of the TRANSCEND trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | TRANSCEND. Combined Endpoint of Doubling Serum Creatinine, Progression to ESRD, New Microalbuminuria or New Macroalbuminuria | 357 participants |
| Telmisartan (ONTARGET) | TRANSCEND. Combined Endpoint of Doubling Serum Creatinine, Progression to ESRD, New Microalbuminuria or New Macroalbuminuria | 448 participants |
p-value: 0.001595% CI: [0.69, 0.92]Regression, Cox
Secondary
TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
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.
Time frame: 56 months
Population: FAS of the TRANSCEND trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke | 384 participants |
| Telmisartan (ONTARGET) | TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke | 440 participants |
p-value: 0.048395% CI: [0.76, 1]Regression, Cox
Secondary
TRANSCEND. Doubling of Serum Creatinine
TRANSCEND. Nephropathy subcategory: doubling of serum creatinine
Time frame: 56 months
Population: FAS of the TRANSCEND trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | TRANSCEND. Doubling of Serum Creatinine | 62 participants |
| Telmisartan (ONTARGET) | TRANSCEND. Doubling of Serum Creatinine | 40 participants |
p-value: 0.024595% CI: [1.06, 2.35]Regression, Cox
Secondary
TRANSCEND. Hospitalization for Congestive Heart Failure
Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).
Time frame: 56 months
Population: FAS of the TRANSCEND trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | TRANSCEND. Hospitalization for Congestive Heart Failure | 134 participants |
| Telmisartan (ONTARGET) | TRANSCEND. Hospitalization for Congestive Heart Failure | 129 participants |
p-value: 0.69495% CI: [0.82, 1.34]Regression, Cox
Secondary
TRANSCEND. Newly Diagnosed Congestive Heart Failure
Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).
Time frame: 56 months
Population: FAS of the TRANSCEND trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | TRANSCEND. Newly Diagnosed Congestive Heart Failure | 187 participants |
| Telmisartan (ONTARGET) | TRANSCEND. Newly Diagnosed Congestive Heart Failure | 191 participants |
p-value: 0.897495% CI: [0.81, 1.21]Regression, Cox
Secondary
TRANSCEND. Newly Diagnosed Diabetes
Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint Newly diagnosed Diabetes. Only calculated for those patients without diabetes at baseline.
Time frame: 56 months
Population: Only for patients of TRANSCEND trial treated with Telmisartan 80mg or Telmisartan 80mg placebo daily for 56 months without diabetes at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | TRANSCEND. Newly Diagnosed Diabetes | 124 participants |
| Telmisartan (ONTARGET) | TRANSCEND. Newly Diagnosed Diabetes | 165 participants |
p-value: 0.017295% CI: [0.6, 0.95]Regression, Cox
Secondary
TRANSCEND. New Macroalbuminuria
TRANSCEND. Nephropathy subcategory: New macroalbuminuria. New macroalbuminuria is defined as UACR ≥300 mg/g creatinine \[Crea\] in patients with a UACR \<300 mg/g Crea at baseline
Time frame: 56 months
Population: FAS of the TRANSCEND trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | TRANSCEND. New Macroalbuminuria | 66 participants |
| Telmisartan (ONTARGET) | TRANSCEND. New Macroalbuminuria | 101 participants |
p-value: 0.008595% CI: [0.48, 0.9]Regression, Cox
Secondary
TRANSCEND. New Microalbuminuria
TRANSCEND. Nephropathy subcategory: New microalbuminuria. New microalbuminuria is defined as UACR ≥30 mg/g creatinine \[Crea\] in patients with a UACR \<30 mg/g Crea at baseline
Time frame: 56 months
Population: FAS of the TRANSCEND trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | TRANSCEND. New Microalbuminuria | 276 participants |
| Telmisartan (ONTARGET) | TRANSCEND. New Microalbuminuria | 363 participants |
p-value: 0.000695% CI: [0.65, 0.89]Regression, Cox
Secondary
TRANSCEND. New Onset of Atrial Fibrillation
Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).
Time frame: 56 months
Population: FAS of the TRANSCEND trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | TRANSCEND. New Onset of Atrial Fibrillation | 181 participants |
| Telmisartan (ONTARGET) | TRANSCEND. New Onset of Atrial Fibrillation | 182 participants |
p-value: 0.956395% CI: [0.82, 1.24]Regression, Cox
Secondary
TRANSCEND. Non-fatal Myocardial Infarction
Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint non-fatal myocardial infarction.
Time frame: 56 months
Population: FAS of the TRANSCEND trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | TRANSCEND. Non-fatal Myocardial Infarction | 114 participants |
| Telmisartan (ONTARGET) | TRANSCEND. Non-fatal Myocardial Infarction | 145 participants |
p-value: 0.057495% CI: [0.62, 1.01]Regression, Cox
Secondary
TRANSCEND. Non-fatal Stroke
Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).
Time frame: 56 months
Population: FAS of the TRANSCEND trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | TRANSCEND. Non-fatal Stroke | 112 participants |
| Telmisartan (ONTARGET) | TRANSCEND. Non-fatal Stroke | 136 participants |
p-value: 0.136595% CI: [0.64, 1.06]Regression, Cox
Secondary
TRANSCEND. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria
TRANSCEND. Nephropathy subcategory: Normalisation from micro- or macroalbuminuria to normoalbuminuria. Normalisation from micro- or macroalbuminuria to normoalbuminuria is defined as UACR \<30 mg/g Crea in patients with a UACR ≥30 mg/g Crea at baseline.
Time frame: 56 months
Population: FAS of the TRANSCEND trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | TRANSCEND. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria | 135 participants |
| Telmisartan (ONTARGET) | TRANSCEND. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria | 110 participants |
p-value: 0.010195% CI: [1.08, 1.79]Regression, Cox
Secondary
TRANSCEND. Progression to ESRD
TRANSCEND. Nephropathy subcategory: Progression to ESRD. Progression to ESRD is defined as initiation of dialysis, need for renal transplantation, or eGFR \<15 mL/min/1.73m²
Time frame: 56 months
Population: FAS of the TRANSCEND trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan/Ramipril (ONTARGET) | TRANSCEND. Progression to ESRD | 11 participants |
| Telmisartan (ONTARGET) | TRANSCEND. Progression to ESRD | 14 participants |
p-value: 0.579895% CI: [0.36, 1.76]Regression, Cox