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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00326768 |
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 HCTZ 12.5 mg in patients with essential hypertension.
Condition | Intervention | Phase |
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Hypertension |
Drug: Telmisartan 40 mg/HCTZ 12.5 mg Drug: Telmisartan 40 mg Drug: Telmisartan 80 mg/HCTZ 12.5 mg |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Long-Term (52-Week), Safety Trial of the Fixed Dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 12.5mg and Telmisartan 40mg Plus Hydrochlorothiazide 12.5mg in Patients With Essential Hypertension - Efficacy and Safety Evaluation |
Estimated Enrollment: | 130 |
Estimated Study Completion Date: | August 2007 |
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 recruitment period will be about three months from the start of the study.
Study Hypothesis:
The primary objective of this study is to demonstrate the long-term safety of a fixed dose combination of telmisartan/HCTZ fixed-dose combination treatment. This study has no control group; therefore, no hypothesis testing will be performed.
Comparison(s):
This study has no control group.
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Essential hypertensive patients who meet the following criteria:
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
Japan | |
Boehringer Ingelheim Investigational Site | |
Sapporo-shi, Hokkaido, Japan, 060-0003 | |
Boehringer Ingelheim Investigational Site | |
Shinjuku-ku, Tokyo, Japan, 160-0023 | |
Boehringer Ingelheim Investigational Site | |
Hiroshima-shi, Hiroshima, Japan, 733-0011 |
Study Chair: | Boehringer Ingelheim Study Coordinator | Nippon Boehringer Ingelheim Co., Ltd. |
Study ID Numbers: | 502.516 |
Study First Received: | May 16, 2006 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00326768 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Anti-Infective Agents Essential Hypertension Benzoates Diuretics Sodium Chloride Symporter Inhibitors Vascular Diseases Cardiovascular Agents Antihypertensive Agents |
Angiotensin II Hydrochlorothiazide Protease Inhibitors Angiotensin II Type 1 Receptor Blockers Antifungal Agents Angiotensin-Converting Enzyme Inhibitors Telmisartan Hypertension |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Benzoates Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Vascular Diseases Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Hydrochlorothiazide |
Pharmacologic Actions Protease Inhibitors Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Natriuretic Agents Antifungal Agents Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Telmisartan Hypertension |