CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 31,546 enrolled
Drug / intervention
Telmisartan +2 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • Prior myocardial infarction (>2 days before consent) or stable/previous unstable angina (>30 days before consent) with multivessel CAD or positive stress test
  • Multivessel PTCA (>30 days before consent) or previous multivessel CABG without angina (if >4 years before consent) or with recurrent angina after surgery
  • Peripheral arterial disease: prior limb bypass surgery/angioplasty/amputation, or intermittent claudication with ankle/arm BP ratio <0.8, or significant stenosis on angiography/non-invasive testing
  • Prior stroke or transient ischemic attack (>7 days and <1 year before consent)
Key exclusion· 12
  • Unable to discontinue ACE inhibitors or ARBs (except ACE-I intolerant patients can enter TRANSCEND)
  • Known hypersensitivity or intolerance to ARBs or ACE inhibitors (except TRANSCEND allows ACE-I intolerant patients)
  • Symptomatic congestive heart failure
  • Hemodynamically significant primary valvular or outflow tract obstruction (e.g., aortic/mitral stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00153101
NCT00153101Phase 4Completed

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.

Boehringer Ingelheim·interventional·Posted Sep 12, 2005·Updated May 20, 2014

In Brief

A Phase 4 clinical trial evaluating Telmisartan, Combination of Telmisartan and Ramipril, and 1 other intervention for Cardiovascular Diseases. Completed, enrolled 31,546 participants across 732 sites in 41 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, 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
Collaborators--

Timeline

Phase 4CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2005
Enrollment StartNov 1, 2001
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 20.8 years ago

Interventions

Telmisartandrug

Combination of Telmisartan and Ramiprildrug

Ramiprildrug