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

Hypertension Clinical Trial

Official title:

Long-Term Study For Amlodipine 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443456
• Other study ID #: A0531086
• Status: Completed
• Phase: Phase 3
• First received: March 2, 2007
• Last updated: October 19, 2009
• Start date: May 2007
• Est. completion date: June 2008

Study information

• Verified date: October 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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).

Description:

NCT00415623 (protocol A0531085)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Chikushino	Fukuoka
Japan	Pfizer Investigational Site	Edogawa-ku	Tokyo
Japan	Pfizer Investigational Site	Fukuoka
Japan	Pfizer Investigational Site	Iruma	Saitama
Japan	Pfizer Investigational Site	Kitakyushu	Fukuoka
Japan	Pfizer Investigational Site	Koshigaya	Saitama
Japan	Pfizer Investigational Site	Setagaya-ku	Tokyo
Japan	Pfizer Investigational Site	Sumida-ku	Tokyo
Japan	Pfizer Investigational Site	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Systolic Blood Pressure From Baseline of the Preceding Study		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	No
Primary	Change in Systolic Blood Pressure From Baseline of This Long-term Study		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	No
Primary	Change in Diastolic Blood Pressure From Baseline of the Preceding Study		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	No
Primary	Change in Diastolic Blood Pressure From Baseline of This Long-term Study		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	No
Primary	Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value		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	No
Primary	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		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	No

External Links

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