Long Term Study For Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Amlodipine (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
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).
Clinical Details
Official title: Long-Term Study For Amlodipine 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To evaluate the long-term safety of Amlodipine 10mg in Adverse events, Laboratory tests, Body weight,12 lead-ECG.
Secondary outcome: Change from baseline of the preceding study (protocol A0531085)Rate of subjects showing the target blood pressure value* Rate of subjects showing the target blood pressure value* and decrease from baseline of preceding study (protocol A0531085) in SBP of >=10mmHg. * = The target blood pressure value in guidelines for the management of hypertension (≦64 years; SBP below 130 mmHg and DBP below 85 mmHg, >=65 years; SBP below 140 mmHg and DBP below 90 mmHg.
Eligibility
Minimum age: 20 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients who complete the preceding study A0531085, Phase III study, who the
investigator have judged to be able to further treatment of long term administration
in terms of efficacy and safety
Exclusion Criteria:
- The patient who does not meet the discontinuation criteria in the preceding study
A0531085.
Locations and Contacts
Pfizer Investigational Site, Fukuoka, Japan
Pfizer Investigational Site, Chikushino, Fukuoka, Japan
Pfizer Investigational Site, Kitakyushu, Fukuoka, Japan
Pfizer Investigational Site, Yokohama, Kanagawa, Japan
Pfizer Investigational Site, Koshigaya, Saitama, Japan
Pfizer Investigational Site, Iruma, Saitama, Japan
Pfizer Investigational Site, Sumida, Tokyo, Japan
Pfizer Investigational Site, Edogawa-ku, Tokyo, Japan
Pfizer Investigational Site, Setagaya-ku, Tokyo, Japan
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: May 2007
Ending date: July 2008
Last updated: June 13, 2008
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