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Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient
This study has been completed.
Study NCT00443456   Information provided by Pfizer
First Received: March 2, 2007   Last Updated: October 19, 2009   History of Changes

March 2, 2007
October 19, 2009
May 2007
June 2008   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
To evaluate the long-term safety of Amlodipine 10mg in Adverse events, Laboratory tests, Body weight,12 lead-ECG, Pulse rate for a total of 52 weeks
Complete list of historical versions of study NCT00443456 on ClinicalTrials.gov Archive Site
 
  • 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.
 
Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient
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)

Phase III
Interventional
Allocation:  Non-Randomized
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Single Group Assignment
Masking:  Open Label
Primary Purpose:  Treatment
Hypertension
Drug: Amlodipine
Two tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks
Single: Experimental
Intervention: Drug: Amlodipine
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
134
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
20 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00443456
Director, Clinical Trial Disclosure Group, Pfizer
A0531086
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2009

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