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Phase 4 Completed N=31,546 Prevention

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.

Source: ClinicalTrials.gov NCT00153101 ↗
Enrolled (actual)
31,546
Serious AEs
62.6%
Results posted
Aug 2009
Primary outcomePrimary: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure — 1386; 1423; 1412 participants — p=0.8462

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure
1386; 1423; 1412 0.8462
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
108; 119; 112 0.5461
PRIMARY
TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure
465; 504 0.2192
SECONDARY
ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
1200; 1190; 1210 0.9086
SECONDARY
ONTARGET. Cardiovascular Death
620; 598; 603 0.4535
SECONDARY
ONTARGET. Non-fatal Myocardial Infarction
424; 431; 400 0.2909
SECONDARY
ONTARGET. Non-fatal Stroke
364; 364; 402 0.2248
SECONDARY
ONTARGET. Hospitalization for Congestive Heart Failure
332; 394; 354 0.4984
SECONDARY
ONTARGET. Doubling of Serum Creatinine in Diabetic Nephropathy Patients
30; 24; 23 0.4221
SECONDARY
ONTARGET. Progression to End Stage Renal Disease (ESRD) in Diabetic Nephropathy Patients
30; 24; 32 0.6248
SECONDARY
ONTARGET. All-cause Mortality in Diabetic Nephropathy Patients
75; 92; 83 0.3682
SECONDARY
ONTARGET. Doubling of Serum Creatinine
167; 160; 149 0.2550
SECONDARY
ONTARGET. Progression to ESRD
79; 67; 71 0.4593
SECONDARY
ONTARGET. New Microalbuminuria
763; 799; 869 0.0133 sig
SECONDARY
ONTARGET. New Macroalbuminuria
205; 229; 257 0.0213 sig
SECONDARY
ONTARGET. Combined Endpoint of Doubling of Serum Creatinine, Progression to ESRD, New Microalbuminuria, or New Macroalbuminuria
1067; 1101; 1190 0.0111 sig
SECONDARY
ONTARGET. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria
508; 483; 448 0.0082 sig
SECONDARY
ONTARGET. Newly Diagnosed Congestive Heart Failure
469; 529; 503 0.3732
SECONDARY
ONTARGET. Cardiovascular Revascularization Procedure
1303; 1290; 1269 0.2713
SECONDARY
ONTARGET. Newly Diagnosed Diabetes
224; 277; 249 0.3485
SECONDARY
ONTARGET. Cognitive Decline
561; 600; 577 0.8690
SECONDARY
ONTARGET. New Onset of Atrial Fibrillation
542; 560; 586 0.2666
SECONDARY
TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
384; 440 0.0483 sig
SECONDARY
TRANSCEND. Cardiovascular Death
227; 223 0.7764
SECONDARY
TRANSCEND. Non-fatal Myocardial Infarction
114; 145 0.0574
SECONDARY
TRANSCEND. Non-fatal Stroke
112; 136 0.1365
SECONDARY
TRANSCEND. Hospitalization for Congestive Heart Failure
134; 129 0.6940
SECONDARY
TRANSCEND. Doubling of Serum Creatinine
62; 40 0.0245 sig
SECONDARY
TRANSCEND. Progression to ESRD
11; 14 0.5798
SECONDARY
TRANSCEND. New Microalbuminuria
276; 363 0.0006 sig
SECONDARY
TRANSCEND. New Macroalbuminuria
66; 101 0.0085 sig
SECONDARY
TRANSCEND. Combined Endpoint of Doubling Serum Creatinine, Progression to ESRD, New Microalbuminuria or New Macroalbuminuria
357; 448 0.0015 sig
SECONDARY
TRANSCEND. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria
135; 110 0.0101 sig
SECONDARY
TRANSCEND. New Onset of Atrial Fibrillation
181; 182 0.9563
SECONDARY
TRANSCEND. Cognitive Decline
230; 192 0.0868
SECONDARY
TRANSCEND. Newly Diagnosed Diabetes
124; 165 0.0172 sig
SECONDARY
TRANSCEND. Cardiovascular Revascularization Procedure
351; 390 0.1431
SECONDARY
TRANSCEND. Newly Diagnosed Congestive Heart Failure
187; 191 0.8974

Eligibility Criteria

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:

  • Peripheral Arterial Disease: Previous limb bypass surgery or angioplasty or amputation, intermittent claudication on history with ankle/arm Blood Pressure ratio 7 days and 160/100).
  • Heart transplant recipient.
  • Strokes due to subarachnoid hemorrhage

C. Other conditions:

  • Significant renal disease defined as:
  • Renal artery stenosis;
  • Creatinine clearance 265 umol/L (> 3.0 mg/dL);
  • Hyperkalemia: potassium > 5.5 mmol/L.
  • Proteinuria* (for TRANSCEND only).
  • 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.
  • Uncorrected volume depletion or sodium depletion.
  • Primary aldosteronism.
  • Hereditary fructose intolerance.
  • Any other major non-cardiac illness expected to reduce life expectancy or interfere with study participation.
  • Patient is simultaneously taking another experimental drug.
  • Patient with significant disability that precludes regular attendance at clinic for follow-up.
  • Patient has sufficient disability or other incapacity that precludes regular attendance at clinic for follow-up.
  • Unable or unwilling to provide written informed consent.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00153101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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