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

Tracking Information

First Received Date ^ICMJE

March 2, 2007

Last Updated Date

October 19, 2009

Start Date ^ICMJE

May 2007

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00443456 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

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.

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Non-Randomized
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Single Group Assignment
Masking:  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 / Comparison Groups

Single: Experimental

Intervention: Drug: Amlodipine

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

134

Completion Date

June 2008

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

Gender

Both

Ages

20 Years to 79 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00443456

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer

Study ID Numbers ^ICMJE

A0531086

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

October 2009

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