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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00443456 |
To investigate the safety and efficacy of the long-term use of amlodipine 10 mg in subjects who will be able to enter a long-term study after completing the parent study "A double-blind comparative study between amlodipine 5 mg and 10 mg in patients with essential hypertension for whom amlodipine 5 mg is insufficiently effective" (Protocol No.: A0531085).
Condition | Intervention | Phase |
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Hypertension |
Drug: Amlodipine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Long-Term Study For Amlodipine 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective |
Enrollment: | 134 |
Study Start Date: | May 2007 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Single: Experimental |
Drug: Amlodipine
Two tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks
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Ages Eligible for Study: | 20 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
Pfizer Investigational Site | |
Fukuoka, Japan | |
Japan, Fukuoka | |
Pfizer Investigational Site | |
Chikushino, Fukuoka, Japan | |
Pfizer Investigational Site | |
Kitakyushu, Fukuoka, Japan | |
Japan, Kanagawa | |
Pfizer Investigational Site | |
Yokohama, Kanagawa, Japan | |
Japan, Saitama | |
Pfizer Investigational Site | |
Koshigaya, Saitama, Japan | |
Pfizer Investigational Site | |
Iruma, Saitama, Japan | |
Japan, Tokyo | |
Pfizer Investigational Site | |
Sumida, Tokyo, Japan | |
Pfizer Investigational Site | |
Edogawa-ku, Tokyo, Japan | |
Pfizer Investigational Site | |
Setagaya-ku, Tokyo, Japan |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A0531086 |
Study First Received: | March 2, 2007 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00443456 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Calcium, Dietary Vasodilator Agents Essential Hypertension Vascular Diseases Calcium Channel Blockers |
Cardiovascular Agents Antihypertensive Agents Amlodipine Hypertension |
Membrane Transport Modulators Vasodilator Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Vascular Diseases Calcium Channel Blockers |
Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Amlodipine Hypertension |