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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.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00153101
First Posted: September 12, 2005
Last Update Posted: May 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boehringer Ingelheim
Results First Submitted: June 15, 2009  
Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment;   Primary Purpose: Prevention
Condition: Cardiovascular Diseases
Interventions: Drug: Telmisartan
Drug: Combination of Telmisartan and Ramipril
Drug: Ramipril

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Telmisartan/Ramipril (ONTARGET) Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan (ONTARGET) Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril (ONTARGET) Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Telmisartan (TRANSCEND) Telmisartan 80mg tablet, one tablet administered once daily in the morning.
Placebo (TRANSCEND) Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.

Participant Flow:   Overall Study
    Telmisartan/Ramipril (ONTARGET)   Telmisartan (ONTARGET)   Ramipril (ONTARGET)   Telmisartan (TRANSCEND)   Placebo (TRANSCEND)
STARTED   8502   8542   8576   2954   2972 
COMPLETED   8485   8524   8561   2946   2962 
NOT COMPLETED   17   18   15   8   10 
Lost to Follow-up                14                14                12                5                5 
Withdrawal by Subject                3                4                3                3                5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis Set (FAS) followed the intent-to-treat principle; it included all patients who were randomised and had any follow-up information available (i.e. 'date last seen' was available for these patients).

Reporting Groups
  Description
Telmisartan/Ramipril (ONTARGET) Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
Telmisartan (ONTARGET) Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
Ramipril (ONTARGET) Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
Telmisartan (TRANSCEND) Telmisartan 80mg tablet, one tablet administered once daily in the morning.
Placebo (TRANSCEND) Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
Total Total of all reporting groups

Baseline Measures
   Telmisartan/Ramipril (ONTARGET)   Telmisartan (ONTARGET)   Ramipril (ONTARGET)   Telmisartan (TRANSCEND)   Placebo (TRANSCEND)   Total 
Overall Participants Analyzed 
[Units: Participants]
 8502   8542   8576   2954   2972   31546 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.4  (7.3)   66.4  (7.1)   66.4  (7.2)   66.9  (7.3)   66.9  (7.4)   66.5  (7.2) 
Gender 
[Units: Participants]
           
Female   2250   2250   2331   1280   1267   9378 
Male   6252   6292   6245   1674   1705   22168 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure   [ Time Frame: 56 months ]

2.  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   [ Time Frame: 56 months ]

3.  Primary:   TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure   [ Time Frame: 56 months ]

4.  Secondary:   ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke   [ Time Frame: 56 months ]

5.  Secondary:   ONTARGET. Cardiovascular Death   [ Time Frame: 56 months ]

6.  Secondary:   ONTARGET. Non-fatal Myocardial Infarction   [ Time Frame: 56 months ]

7.  Secondary:   ONTARGET. Non-fatal Stroke   [ Time Frame: 56 months ]

8.  Secondary:   ONTARGET. Hospitalization for Congestive Heart Failure   [ Time Frame: 56 months ]

9.  Secondary:   ONTARGET. Doubling of Serum Creatinine in Diabetic Nephropathy Patients   [ Time Frame: 56 months ]

10.  Secondary:   ONTARGET. Progression to End Stage Renal Disease (ESRD) in Diabetic Nephropathy Patients   [ Time Frame: 56 months ]

11.  Secondary:   ONTARGET. All-cause Mortality in Diabetic Nephropathy Patients   [ Time Frame: 56 months ]

12.  Secondary:   ONTARGET. Doubling of Serum Creatinine   [ Time Frame: 56 months ]

13.  Secondary:   ONTARGET. Progression to ESRD   [ Time Frame: 56 months ]

14.  Secondary:   ONTARGET. New Microalbuminuria   [ Time Frame: 56 months ]

15.  Secondary:   ONTARGET. New Macroalbuminuria   [ Time Frame: 56 months ]

16.  Secondary:   ONTARGET. Combined Endpoint of Doubling of Serum Creatinine, Progression to ESRD, New Microalbuminuria, or New Macroalbuminuria   [ Time Frame: 56 months ]

17.  Secondary:   ONTARGET. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria   [ Time Frame: 56 months ]

18.  Secondary:   ONTARGET. Newly Diagnosed Congestive Heart Failure   [ Time Frame: 56 months ]

19.  Secondary:   ONTARGET. Cardiovascular Revascularization Procedure   [ Time Frame: 56 months ]

20.  Secondary:   ONTARGET. Newly Diagnosed Diabetes   [ Time Frame: 56 months ]

21.  Secondary:   ONTARGET. Cognitive Decline   [ Time Frame: 56 months ]

22.  Secondary:   ONTARGET. New Onset of Atrial Fibrillation   [ Time Frame: 56 months ]

23.  Secondary:   TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke   [ Time Frame: 56 months ]

24.  Secondary:   TRANSCEND. Cardiovascular Death   [ Time Frame: 56 months ]

25.  Secondary:   TRANSCEND. Non-fatal Myocardial Infarction   [ Time Frame: 56 months ]

26.  Secondary:   TRANSCEND. Non-fatal Stroke   [ Time Frame: 56 months ]

27.  Secondary:   TRANSCEND. Hospitalization for Congestive Heart Failure   [ Time Frame: 56 months ]

28.  Secondary:   TRANSCEND. Doubling of Serum Creatinine   [ Time Frame: 56 months ]

29.  Secondary:   TRANSCEND. Progression to ESRD   [ Time Frame: 56 months ]

30.  Secondary:   TRANSCEND. New Microalbuminuria   [ Time Frame: 56 months ]

31.  Secondary:   TRANSCEND. New Macroalbuminuria   [ Time Frame: 56 months ]

32.  Secondary:   TRANSCEND. Combined Endpoint of Doubling Serum Creatinine, Progression to ESRD, New Microalbuminuria or New Macroalbuminuria   [ Time Frame: 56 months ]

33.  Secondary:   TRANSCEND. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria   [ Time Frame: 56 months ]

34.  Secondary:   TRANSCEND. New Onset of Atrial Fibrillation   [ Time Frame: 56 months ]

35.  Secondary:   TRANSCEND. Cognitive Decline   [ Time Frame: 56 months ]

36.  Secondary:   TRANSCEND. Newly Diagnosed Diabetes   [ Time Frame: 56 months ]

37.  Secondary:   TRANSCEND. Cardiovascular Revascularization Procedure   [ Time Frame: 56 months ]

38.  Secondary:   TRANSCEND. Newly Diagnosed Congestive Heart Failure   [ Time Frame: 56 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00153101     History of Changes
Obsolete Identifiers: NCT00034931
Other Study ID Numbers: 502.373
First Submitted: September 9, 2005
First Posted: September 12, 2005
Results First Submitted: June 15, 2009
Results First Posted: August 25, 2009
Last Update Posted: May 20, 2014