Please select the outcome measures that correspond to the clinical trial below.
Title: ONTARGET ONgoing Telmisartan Alone and in Combination With Ramipril Global Endpoint Trial A Large, Simple Randomized Trial of an Angiotensin II Receptor Antagonist (Telmisartan) and an ACE-Inhibitor (Ramipril) in Patients at High Risk for Cardiovascular Events and TRANSCEND Telmisartan Randomized AssessmeNt Study in aCE iNtolerant Subjects With Cardiovascular Disease. A Parallel Study Comparing the Effects of Telmisartan With Placebo and Outcomes in Patients at High Risk for Cardiovascular Events and Intolerant to ACE-I.
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.


Options:
A: Percentage of Participants With Occurrence of Primary Composite Endpoint (Core : Active Treatment Phase) (Time from randomization to the first event (Maximum 50 months)); Percentage of Participants With Cardiovascular (CV) Death (Core: Active Treatment Phase) (Time from randomization to the first event (Maximum 50 months)); Percentage of Participants With Resuscitated Sudden Death (Core: Active Treatment Phase) (Time from randomization to the first event (Maximum 50 Months)); Percentage of Participants With Fatal/Non-fatal Myocardial Infarction (MI) (Core: Active Treatment Phase) (Time from randomization to the first event (Maximum 50 Months)); Percentage of Participants With Fatal/Non-fatal Stroke (Core: Active Treatment Phase) (Time from randomization to the first event (Maximum 50 Months)); Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Core: Active Treatment Phase) (Time from randomization to the first event (Maximum 50 Months)); Percentage of Participants With Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Core: Active Treatment Phase) (Time from randomization to the first event (Maximum 50 Months)); Percentage of Participants With Unplanned Hospitalization for Heart Failure (Core: Active Treatment Phase) (Time from randomization to the first event (Maximum 50 Months)); Percentage of Participants With All Cause Mortality (Core: Active Treatment Phase) (Time from randomization to the first event (Maximum 50 months)); Percentage of Participants With Occurrence of Primary Composite Endpoint (Extension Phase) (From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)); Percentage of Participants With Cardiovascular (CV) Death (Extension Phase) (from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)); Percentage of Participants With Resuscitated Sudden Death (Extension Phase) (From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)); Percentage of Participants Fatal/Non-fatal Myocardial Infarction (MI) (Extension Phase) (From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 month in average)); Percentage of Participants With Fatal/Non-fatal Stroke (Extension Phase) (From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)); Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Extension Phase) (From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)); Percentage of Participants Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Extension Phase) (From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)); Percentage of Participants With Unplanned Hospitalization for Heart Failure (Extension Phase) (From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)); Percentage of Participants With All Cause Mortality (Extension Phase) (from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average))
B: Blood pressure variation and proportion of use of add-on drugs (18 months); Adverse events (18 months); Development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. (18 monyhs)
C: Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks (Baseline, 8 weeks, 16 weeks, and 24 weeks); Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24 (Baseline to 24 weeks)
D: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); 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); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)

Answer: D