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Filtered Trial for Amlodipine Non-responder
This study has been completed.

First Received on October 29, 2007.   Last Updated on February 8, 2010   History of Changes
Sponsor: 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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Filtered Trial for Amlodipine Non-responder

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks [ Time Frame: Baseline and 8 Weeks ]

Secondary Outcome Measures:
  • Decrease in Seated Systolic Blood Pressure From Baseline to 8 Weeks [ Time Frame: Baseline and 8 Weeks ]
  • Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]
  • Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]
  • Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]
  • Percentage of Patients Who Achieved an Adequate Response, Defining Seated Trough Systolic Blood Pressure Was <140 mmHg or Decreased From Reference Baseline by >=20 mmHg at 8 Weeks in Seated Trough Systolic Blood Pressure at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]
  • Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]

Enrollment: 531
Study Start Date: October 2007
Primary Completion Date: September 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 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 diastolic blood pressure (DBP) > 114 mmHg and/or mean seated systolic blood pressure (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 the New York Heart Association (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 angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (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 nonsteroidal anti-inflammatory drugs (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:

    • Pregnant or possibly pregnant (1)
    • Nursing (2)
    • Desire to become pregnant during study period (3)
  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

Locations
Japan
1235.13.037 Boehringer Ingelheim Investigational Site
Azumino, Nagano, Japan
1235.13.023 Boehringer Ingelheim Investigational Site
Higashiosaka, Osaka, Japan
1235.13.021 Boehringer Ingelheim Investigational Site
Itabashi-ku, Tokyo, Japan
1235.13.014 Boehringer Ingelheim Investigational Site
Kashihara, Osaka, Japan
1235.13.038 Boehringer Ingelheim Investigational Site
Kitaazumi-gun, Nagano, Japan
1235.13.009 Boehringer Ingelheim Investigational Site
Kiyose, Tokyo, Japan
1235.13.041 Boehringer Ingelheim Investigational Site
Kobe, Hyogo, Japan
1235.13.035 Boehringer Ingelheim Investigational Site
Komoro, Nagano, Japan
1235.13.027 Boehringer Ingelheim Investigational Site
Koriyama, Fukushima, Japan
1235.13.004 Boehringer Ingelheim Investigational Site
Koriyama, Fukushima, Japan
1235.13.003 Boehringer Ingelheim Investigational Site
Koriyama, Fukushima, Japan
1235.13.007 Boehringer Ingelheim Investigational Site
Koshigaya, Saitama,, Japan
1235.13.008 Boehringer Ingelheim Investigational Site
Koto-ku, Tokyo, Japan
1235.13.005 Boehringer Ingelheim Investigational Site
Matsudo, Chiba, Japan
1235.13.026 Boehringer Ingelheim Investigational Site
Mito, Ibaraki, Japan
1235.13.013 Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan
1235.13.016 Boehringer Ingelheim Investigational Site
Okayama, Okayama,, Japan
1235.13.040 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan
1235.13.025 Boehringer Ingelheim Investigational Site
Saitama, Saitama, Japan
1235.13.031 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1235.13.028 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1235.13.034 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1235.13.001 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1235.13.030 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1235.13.033 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1235.13.024 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan
1235.13.018 Boehringer Ingelheim Investigational Site
Sendai, Miyagi, Japan
1235.13.002 Boehringer Ingelheim Investigational Site
Sendai, Miyagi, Japan
1235.13.019 Boehringer Ingelheim Investigational Site
Sendai, Miyagi, Japan
1235.13.036 Boehringer Ingelheim Investigational Site
Shimoina-gun, Nagano, Japan
1235.13.042 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan
1235.13.010 Boehringer Ingelheim Investigational Site
Shinjyuku-ku, Tokyo, Japan
1235.13.011 Boehringer Ingelheim Investigational Site
Shinjyuku-ku,Tokyo, Japan
1235.13.022 Boehringer Ingelheim Investigational Site
Shizuoka, Shizuoka, Japan
1235.13.015 Boehringer Ingelheim Investigational Site
Suita, Osaka,, Japan
1235.13.032 Boehringer Ingelheim Investigational Site
Takamatsu, Kagawa, Japan
1235.13.029 Boehringer Ingelheim Investigational Site
Takamatsu, Kagawa, Japan
1235.13.017 Boehringer Ingelheim Investigational Site
Takamatsu, Kagawa, Japan
1235.13.012 Boehringer Ingelheim Investigational Site
Takaoka, Toyama, Japan
1235.13.039 Boehringer Ingelheim Investigational Site
Takaoka,Toyama, Japan
1235.13.020 Boehringer Ingelheim Investigational Site
Tsuchiura, Ibaraki, Japan
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00558064     History of Changes
Other Study ID Numbers: 1235.13
Study First Received: October 29, 2007
Results First Received: November 10, 2009
Last Updated: February 8, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on February 09, 2012