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

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NCT00443456

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Study Location
Pfizer Investigational Site
Chikushino, Fukuoka, , Japan
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-79 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- The patient who met the discontinuation criteria in the preceding study A0531085

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Advanced Information
Descriptive Information
Brief Title  ICMJE Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient
Official Title  ICMJE Long-Term Study For Amlodipine 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective
Brief 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).
Detailed Description NCT00415623 (protocol A0531085)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE Drug: Amlodipine
Two tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks
Study Arms  ICMJE Experimental: Single
Intervention: Drug: Amlodipine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2008)		134
Original Enrollment  ICMJE
 (submitted: March 2, 2007)		130
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00443456
Other Study ID Numbers  ICMJE A0531086
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP