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Filtered Trial for Telmisartan 40mg Non-Responder
This study has been completed.
First Received: October 26, 2007   Last Updated: January 27, 2009   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00550953
  Purpose

The primary purpose of this study is to:

Demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to telmisartan 40 mg alone in patients with essential hypertension and inadequately controlled with telmisartan 40 mg monotherapy.


Condition Intervention Phase
Hypertension
Drug: telmisartan+amlodipine
Drug: telmisartan
Phase III

Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: Filtered Trial for Telmisartan 40mg Non-Responder

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint is the reduction from reference baseline in mean seated diastolic blood pressure (DBP) at trough (24hr postdosing) after 8 weeks of the double blind treatment. [ Time Frame: 8 Weeks ]

Secondary Outcome Measures:
  • Reduction in seated systolic blood pressure (SBP) Control rate in SBP/DBP Response rate in SBP/DBP Normalisation [ Time Frame: 8 Weeks ]

Enrollment: 314
Study Start Date: October 2007
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Essential hypertensive patients who satisfying non-responder criteria
  2. Male or Female
  3. Age 20 years or older
  4. Outpatient

Exclusion Criteria:

  1. Taking four or more anti-hypertensive medications
  2. Secondary hypertension
  3. Mean seated DBP > 114 mmHg and/or mean seated SBP > 200 mmHg during run-in, or less than 90 mmHg in DBP during T40 mg monotherapy
  4. Sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias
  5. Congestive heart failure patients with NYHA functional class III-IV
  6. History of myocardial infarction or cardiac surgery within last 6 months
  7. History of coronary artery bypass graft or percutaneous coronary intervention (PCI) within last 3 months
  8. History of unstable angina within last 3 months
  9. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve
  10. History of stroke or transient ischemic attack within last 6 months
  11. History of sudden exacerbation of renal function with ARBs or ACE inhibitors, or patients with post-renal transplant or post-nephrectomy
  12. Experienced characteristic symptoms of angioedema during treatment with ARBs or ACE inhibitors
  13. Known hypersensitivity to any component of the investigational drug, or a known hypersensitivity to dihydropyridine -derived drugs
  14. Hepatic and/or renal dysfunction
  15. Diagnosed biliary atresia or cholestasis
  16. Hyperkalemia
  17. Dehydration
  18. Sodium deficiency
  19. Chronic administration of high doses of acidic NSAIDs
  20. Patients who cannot change to the restricted administration and dosage during study period
  21. Pre-menopausal women who meet any one of the following 1) - 3):

1) Pregnant or possibly pregnant 2) Nursing 3) Desire to become pregnant during study period 22. Drug or alcohol dependency 23. Complication of malignant tumour or a disease requiring immunosuppressants 24. Compliance of < 80% or > 120% during the run-in period 25. Receiving any investigational therapy within 3 months 26. Judged to be inappropriate by the investigator or the sub-investigator

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00550953

Locations
Japan
1235.14.001 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan
1235.14.002 Boehringer Ingelheim Investigational Site
Chofu, Tokyo, Japan
1235.14.003 Boehringer Ingelheim Investigational Site
Musashino, Tokyo, Japan
1235.14.004 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan
1235.14.005 Boehringer Ingelheim Investigational Site
Nishi-ku, Hiroshima, Hiroshima, Japan
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1235.14
Study First Received: October 26, 2007
Last Updated: January 27, 2009
ClinicalTrials.gov Identifier: NCT00550953     History of Changes
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors
Amlodipine
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Telmisartan
Hypertension

ClinicalTrials.gov processed this record on November 20, 2009