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Filtered Trial for Telmisartan 40mg Non-responder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00550953
Recruitment Status : Completed
First Posted : October 30, 2007
Results First Posted : February 2, 2010
Last Update Posted : January 30, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Brief Summary:

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 or disease Intervention/treatment Phase
Hypertension Drug: telmisartan+amlodipine Drug: telmisartan Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Filtered Trial for Telmisartan 40mg Non-responder
Study Start Date : October 2007
Actual Primary Completion Date : July 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan




Primary Outcome Measures :
  1. Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks [ Time Frame: Baseline and 8 Weeks ]
    The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.


Secondary Outcome Measures :
  1. Decrease in Seated Systolic Blood Pressure From Baseline to 8 Weeks [ Time Frame: Baseline and 8 weeks ]
    The mean of the change value was least square mean which was calculated by analysis of covariance with factor treatment and center, and covariate baseline.

  2. Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]
    Seated trough diastolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake

  3. Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]
    Seated trough systolic blood pressure defined as blood pressure in a sitting position no later than 24 hours after the last intake

  4. 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 ]
    Adequate response defined that seated trough diastolic blood pressure was <90 mmHg or decreased from reference baseline by >=10 mmHg at 8 weeks

  5. Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]
    Adequate response defined that seated trough systolic blood pressure was <140 mmHg or decreased from reference baseline by >=20 mmHg at 8 weeks (0 percent at baseline)

  6. Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]

    Optimal, normal, high normal blood pressure were defined as follows:

    • Optimal: Systolic blood pressure (SBP) < 120 mmHg and diastolic blood pressure (DBP) < 80 mmHg
    • Normal: SBP >= 120 mmHg or DBP >= 80 mmHg and SBP < 130 mmHg and DBP < 85 mmHg
    • High normal: SBP >= 130 mmHg or DBP >= 85 mmHg and SBP < 140 mmHg and DBP < 90 mmHg

  7. Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG [ Time Frame: First administration of randomised treatment to 24 hours post last dose of randomised treatment ]
    Clinical relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00550953


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

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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00550953    
Other Study ID Numbers: 1235.14
First Posted: October 30, 2007    Key Record Dates
Results First Posted: February 2, 2010
Last Update Posted: January 30, 2014
Last Verified: December 2013
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Telmisartan
Telmisartan amlodipine combination
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists