Status:
COMPLETED
Trial of Telmisartan 80 mg/HCTZ 12.5 mg and Telmisartan 40 mg/HCTZ 12.5 mg in Patients With Hypertension
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hypertension
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
Brief Summary
The objective of this trial is to assess the safety and efficacy of 52 weeks of open-label treatment with the fixed dose combination of telmisartan 80 mg plus HCTZ 12.5 mg and telmisartan 40 mg plus H...
Detailed Description
This is a multi-centre study with three centres participating with a target of 30 to 90 patients entering the maintenance period and 20-60 patients completing long-term treatment per centre. The recru...
Eligibility Criteria
Inclusion
- Essential hypertensive patients who meet the following criteria:
- In case of using any antihypertensives, mean seated DBP\* must be over 90 and under 114 mmHg at Visit 1
- In case of not using any antihypertensives, mean seated DBP\* must be over 95 and under 114 mmHg at Visit 1
- Mean seated DBP\* must be over 90 at Visit 2 (\* The mean DBP values will be calculated as the average of three seated measurements taken at two-minute intervals).
- Age over 20 and under 80 years at Visit 1 (Male or Female)
- Outpatient
- Patients who are able to stop current anti-hypertensive therapy at Visit 1 if taking any anti-hypertensive medications
- 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.
- 1\. Patients taking four or more anti-hypertensive medications at Visit 1 2. Patients with known or suspected secondary hypertension (renovascular hypertension, primary aldosteronism, pheochromocytoma, etc.) 3. Patients whose mean seated DBP \> 114 mmHg and/or mean seated SBP \> 200 mmHg at Visit 1, Visit 2 or Visit 3 4. Patients with sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias (AV-block II-III, atrial fibrillation etc.) 5. Patients with NYHA functional class heart failure III-IV 6. Patients with a history of myocardial infarction or cardiac surgery within last 6 3 months before signing the informed consent form 7. Patients with a history of coronary artery bypass surgery or percutaneous transluminal coronary angioplasty (PTCA) within last 3 months before signing the informed consent form 8. Patients with a history of unstable angina within last 3 months before signing the informed consent form 9. Patients with hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve 10. Patients with a history of stroke or transient ischemic attack within last 6 months before signing the informed consent form 11. Patients with a history of sudden exacerbation of renal function with AT1 receptor antagonists or ACE inhibitors; post-renal transplant 12. Patients who have previously experienced characteristic symptoms of angioedema (such as facial, tongue, pharyngeal, or laryngeal swelling with dyspnea) during treatment with AT1 receptor antagonists or ACE inhibitors 13. Patients with known hypersensitivity to any component of the formulation, or a known hypersensitivity to sulfonamides or sulfonamide-derived drugs (e.g. thiazides) 14. Known, suspected or history of gout
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT00326768
Start Date
May 1 2006
End Date
August 1 2007
Last Update
December 28 2017
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Boehringer Ingelheim Investigational Site
Hiroshima-shi, Hiroshima, Japan, 733-0011
2
Boehringer Ingelheim Investigational Site
Sapporo-shi, Hokkaido, Japan, 060-0003
3
Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan, 160-0023