Official Title: “Long-Term Study For Amlodipine 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective”

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).

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

• Drug: Amlodipine
  • Two tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Single

Primary Measures

• To evaluate the long-term safety of Amlodipine 10mg in Adverse events, Laboratory tests, Body weight,12 lead-ECG.
  • Time Frame: Pulse rate for a total of 52 weeks
    Safety Issue?: Yes

Secondary Measures

• * = 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.
  • Time Frame: 52 weeks
    Safety Issue?: No
• Change from baseline of the preceding study (protocol A0531085)
  • Time Frame: 52 weeks
    Safety Issue?: No
• Rate of subjects showing the target blood pressure value*
  • Time Frame: 52 weeks
    Safety Issue?: No
• Rate of subjects showing the target blood pressure value* and decrease from baseline of preceding study (protocol A0531085) in SBP of >=10mmHg.
  • Time Frame: 52 weeks
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 79 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00443456

Study ID Number: A0531086

ClinicalTrials.gov Identifier: NCT00443456

Health Authority: Japan: Ministry of Health, Labor and Welfare

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