Filtered Trial for Amlodipine Non-responder

Official Title: “Filtered Trial for Amlodipine Non-responder”

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.

Intervention(s) in this Clinical Trial

• Drug: telmisartan+amlodipine
• Drug: amlodipine

Primary Measures

• Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks
  • Time Frame: Baseline and 8 Weeks
    

Secondary 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
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Boehringer Ingelheim Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00558064

Study ID Number: 1235.13

ClinicalTrials.gov Identifier: NCT00558064

Health Authority: Japan: Ministry of Health, Labor and Welfare