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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.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00153101
  Purpose

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 CV death, MI, stroke or hospitalization for 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.

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 CV death, MI, stroke or hospitalization for CHF in patients who are intolerant to ACE-I.


Condition Intervention Phase
Cardiovascular Diseases
Drug: Telmisartan
Drug: Combination of Telmisartan and Ramipril
Drug: Ramipril
Phase IV

MedlinePlus related topics: Heart Failure
Drug Information available for: Ramipril Telmisartan Angiotensin II Angiotensin II, ile(5)-
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Parallel Assignment
Official 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.

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Cardiovascular death Non-fatal myocardial infarction Non-fatal stroke Hospitalization for congestive heart failure [ Time Frame: 56months ]

Secondary Outcome Measures:
  • Newly diagnosed congestive heart failure Cardiovascular revascularization procedures Newly diagnosed diabetes Cognitive decline (adjudication will be done by a special committee) 5. New onset of atrial fibrillation 6. Nephropathy [ Time Frame: 56months ]

Enrollment: 31546
Study Start Date: November 2001
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Coronary Artery Disease: Previous MI (> 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 PTCA (> 30 days prior to informed consent), or previous multivessel CABG without angina (if surgery performed > 4 years prior to informed consent) or with recurrent angina after surgery.

Other High Risk:

  1. Peripheral Arterial Disease: Previous limb bypass surgery or angioplasty or amputation, intermittent claudication on history with ankle/arm BP ratio < 0.8 on at least one side, or significant stenosis by angiography or non-invasive testing
  2. Previous stroke
  3. TIA > 7 days and < 1 year prior to informed consent
  4. Diabetes Mellitus (types I or II): with evidence of end-organ damage (retinopathy, LVH, micro or macro albuminuria), or any evidence of previous cardiac or vascular disease.

No definite and specific indication or contraindication for any of the study treatments.

Written informed consent.

Exclusion Criteria:

A. Medication use:

  1. Inability to discontinue ACE-inhibitors or AIIA.
  2. Patients with known hypersensitivity or intolerance to AIIAs or ACE-inhibitors. NOTE: Patients with known intolerance to ACE-I can be enrolled in the TRANSCEND study.

B. Cardiovascular disease:

  1. Symptomatic congestive heart failure.
  2. Hemodynamically significant primary valvular or outflow tract obstruction (e.g. aortic or mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve).
  3. Constrictive pericarditis.
  4. Complex congenital heart disease.
  5. Syncopal episodes of unknown etiology < 3 months before informed consent.
  6. Planned cardiac surgery or angioplasty within three months.
  7. Uncontrolled hypertension on treatment (i.e. BP > 160/100).
  8. Heart transplant recipient.
  9. Strokes due to subarachnoid hemorrhage

C. Other conditions:

  1. Significant renal disease defined as:

    1. Renal artery stenosis;
    2. Creatinine clearance < 0.6 ml/min or serum creatinine > 265 umol/L (> 3.0 mg/dL);
    3. Hyperkalemia: potassium > 5.5 mmol/L.
    4. Proteinuria* (for TRANSCEND only).
  2. Hepatic dysfunction as defined by the following laboratory parameters: SGPT (ALT) or SGOT (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.
  3. Uncorrected volume depletion or sodium depletion.
  4. Primary aldosteronism.
  5. Hereditary fructose intolerance.
  6. Any other major non-cardiac illness expected to reduce life expectancy or interfere with study participation.
  7. Patient is simultaneously taking another experimental drug.
  8. Patient with significant disability that precludes regular attendance at clinic for follow-up.
  9. Patient has sufficient disability or other incapacity that precludes regular attendance at clinic for follow-up.
  10. Unable or unwilling to provide written informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00153101

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Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Publications indexed to this study:
Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 502.373
Study First Received: September 9, 2005
Last Updated: December 9, 2008
ClinicalTrials.gov Identifier: NCT00153101  
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;   Brazil: National Health Surveillance Agency;   Canada: Health Canada;   China: State Food and Drug Administration;   Czech Republic: State Institute for Drug Control (SUKL);   Denmark: Danish Medicines Agency;   Finland: National Agency for Medicines;   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 and Social Development 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

Study placed in the following topic categories:
Telmisartan
Angiotensin II
Ramipril

Additional relevant MeSH terms:
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009