Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00153101
First received: September 9, 2005
Last updated: May 13, 2014
Last verified: May 2014
Results First Received: 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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Hide Limitations and Caveats

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
  Hide More Information

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


No publications provided by Boehringer Ingelheim

Publications automatically indexed to this study:


Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00153101     History of Changes
Obsolete Identifiers: NCT00034931
Other Study ID Numbers: 502.373
Study First Received: September 9, 2005
Results First Received: June 15, 2009
Last Updated: May 13, 2014
Health Authority: Argentina: National Administration of Medicines, Food and Medical Technology
Australia: Responsilble Ethics Committee
Austria: Ministry for Social Security and Generations
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Health Surveillance Agency
Canada: Health Canada
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control (SUKL)
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: AFFSAPS
Germany: Federal Institute for Drugs and Medical Devices
Great Britain: MHRA
Greece: HELLENIC REPUBLIC MINISTRY OF HEALTH AND WELFARE NATIONAL ORGANISATION OF MEDICINES (EOF)
Hong Kong: Dept. of Health, Hong Kong
Hungary: National Institute of Pharmacy (OGYI), H-1051 Budapest
Ireland: The Irish Medicines Board
Italy: Comitato Etico delle Aziende Sanitarie della Regione Umbria
Korea, Republic of: Korea Food and Drug Administration (KFDA)
Malaysia: Drug Control Authority
Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
New Zealand: Multicentre Ethics Committee/Medsafe
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Philippines: Bureau of Pharmaceutical Affairs, Department of Health
Poland: CEBK, Warsaw
Portugal: INFARMED, National Authority of Medicines and Health Products, IP
Russia: Ministry of Health of the Russian Federation
Singapore: Centre of Drug Administration
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
South Africa: Medicines Control Council
Spain: Ministry of Health
Sweden: Medical Product Agency
Switzerland: Swissmedic Schweizerisches Heilmittelinstitut (Swiss Agency for Therapeutic Products)
Taiwan: Dept. of Health, Executive Yuan, Taiwan
Thailand: Bureau of Pharmaceutical Affairs, Department of Health
Turkey: Ministry of Health Central Ethics Committee
Ukraine: State Pharmacology Centre of the Ministry of Health of Ukraine
United Arab. Emirates: Medical Affairs Department of Health and Medical Services, General Authority Health Services, Ministry of Health for Northern Emirates
United States: Food and Drug Administration