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Filtered Trial for Amlodipine Non-Responder

This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, July 2008

Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00558064
  Purpose

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


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

MedlinePlus related topics:   High Blood Pressure   

ChemIDplus related topics:   Telmisartan    Amlodipine    Amlodipine besylate   

U.S. FDA Resources

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

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 (24 hour post dosing) 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 ]

Estimated Enrollment:   380
Study Start Date:   October 2007
Estimated Primary Completion Date:   October 2008 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: telmisartan+amlodipine
    T40mg/A5mg/day
    Drug: amlodipine
    A5mg/day
  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 satisfying all of the following criteria;
  2. Male or Female
  3. Age > 20 years
  4. Outpatient
  5. Patients who are able to stop current anti-hypertensive therapy at Visit 1 if taking any anti-hypertensive medications
  6. Patients with an ability to provide written informed consent in accordance with the related laws and guidelines such as Good Clinical Practice (GCP) and the Pharmaceutical Affairs Law.

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 at Visit 1, 2, 3, or 4, or mean seated DBP < 90 mmHg at Visit 3.
  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: NCT00558064

Contacts
Contact: Boehringer Ingelheim Study Coordinator     clintriage@boehringer-ingelheim.com    

Locations
Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Kiyose, Tokyo, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Nagoya, Aichi, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Koriyama, Fukushima, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Matsudo, Chiba, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Koto-ku, Tokyo, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Shizuoka, Shizuoka, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Sendai, Miyagi, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Saitama, Saitama, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Mito, Ibaraki, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Tsuchiura, Ibaraki, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Sapporo, Hokkaido, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Koshigaya, Saitama,, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Shinjyuku-ku, Tokyo, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Shinjyuku-ku,Tokyo, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Shinjuku-ku, Tokyo, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Kashihara, Osaka, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Suita, Osaka,, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Okayama, Okayama,, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Takamatsu, Kagawa, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Itabashi-ku, Tokyo, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Komoro, Nagano, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Higashiosaka, Osaka, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Shimoina-gun, Nagano, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Azumino, Nagano, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Kitaazumi-gun, Nagano, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Takaoka,Toyama, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Kobe, Hyogo, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Osaka, Osaka, Japan
Boehringer Ingelheim Investigational Site     Recruiting
      Takaoka, Toyama, Japan

Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals

Investigators
Study Chair:     Boehringer Ingelheim     Boehringer Ingelheim Pharmaceuticals    
  More Information


Responsible Party:   Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:   1235.13
First Received:   October 29, 2007
Last Updated:   July 10, 2008
ClinicalTrials.gov Identifier:   NCT00558064
Health Authority:   Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:
Vascular Diseases
Telmisartan
Angiotensin II
Amlodipine
Hypertension

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

ClinicalTrials.gov processed this record on October 07, 2008




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