Filtered Trial for Amlodipine Non-responder

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00558064
First received: October 29, 2007
Last updated: June 24, 2014
Last verified: December 2013
  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 3

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:

Primary Outcome Measures:
  • Reduction From Reference Baseline in Mean Seated Diastolic Blood Pressure at Trough (24-hour Post-dosing) [ Time Frame: Baseline and 8 Weeks ] [ Designated as safety issue: No ]
    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:
  • Reduction From Reference Baseline in Mean Seated Systolic Blood Pressure at Trough (24-hour Post-dosing) [ Time Frame: Baseline and 8 Weeks ] [ Designated as safety issue: No ]
    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.

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

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

  • 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 ] [ Designated as safety issue: No ]
    Adequate response defined that seated trough diastolic blood pressure was <90 mmHg or decreased from reference baseline by >=10 mmHg at 8 weeks

  • Percentage of Patients Who Achieved an Adequate Response in Seated Trough Systolic Blood Pressure at 8 Weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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)

  • Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    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
    • No: SBP >= 140 mmHg and DPB >= 90 mmHg

  • Clinically Relevant Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG [ Time Frame: First administration of randomised treatment to 24 hours post last dose of randomised treatment ] [ Designated as safety issue: No ]
    Clinical relevant abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional 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: June 24, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on September 14, 2014