Filtered Trial for Telmisartan 40mg Non-responder

NCT ID: NCT00550953

Last Updated: 2014-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31

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.

Conditions

Hypertension

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Interventions

telmisartan+amlodipine

Intervention Type: DRUG

telmisartan

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Boehringer Ingelheim

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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

Countries

Japan

Other Identifiers

1235.14

Identifier Type: -

Identifier Source: org_study_id