Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient

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).

NCT00415623 (protocol A0531085)

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

• Change in Systolic Blood Pressure From Baseline of the Preceding Study
  • Time Frame: Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks
    Safety Issue?: No
• Change in Systolic Blood Pressure From Baseline of This Long-term Study
  • Time Frame: Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks
    Safety Issue?: No
• Change in Diastolic Blood Pressure From Baseline of the Preceding Study
  • Time Frame: Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks
    Safety Issue?: No
• Change in Diastolic Blood Pressure From Baseline of This Long-term Study
  • Time Frame: Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks
    Safety Issue?: No
• Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value
  • Time Frame: 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks
    Safety Issue?: No
• Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study
  • Time Frame: 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks
    Safety Issue?: No

Inclusion Criteria:

• Patients who had completed the preceding study A0531085, Phase III study, who the investigator judged to be able to further treatment of long term administration in terms of efficacy and safety
• Patients who had a treatment compliance rate of at least 80%

Exclusion Criteria:

• The patient who met 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 Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

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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