Long Term Study For Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00443456

Purpose

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).

Condition	Intervention	Phase
Hypertension	Drug: Amlodipine	Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Long-Term Study For Amlodipine 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective

Further study details as provided by Pfizer:

Primary Outcome Measures:

To evaluate the long-term safety of Amlodipine 10mg in Adverse events, Laboratory tests, Body weight,12 lead-ECG. [ Time Frame: Pulse rate for a total of 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

* = 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. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Change from baseline of the preceding study (protocol A0531085) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Rate of subjects showing the target blood pressure value* [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Rate of subjects showing the target blood pressure value* and decrease from baseline of preceding study (protocol A0531085) in SBP of >=10mmHg. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment:	134
Study Start Date:	May 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single: Experimental	Drug: Amlodipine Two tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks

Eligibility

Ages Eligible for Study:	20 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who complete the preceding study A0531085, Phase III study, who the investigator have judged to be able to further treatment of long term administration in terms of efficacy and safety

Exclusion Criteria:

The patient who does not meet the discontinuation criteria in the preceding study A0531085.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443456

Locations

Japan
Pfizer Investigational Site
Fukuoka, Japan
Japan, Fukuoka
Pfizer Investigational Site
Chikushino, Fukuoka, Japan
Pfizer Investigational Site
Kitakyushu, Fukuoka, Japan
Japan, Kanagawa
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Japan, Saitama
Pfizer Investigational Site
Koshigaya, Saitama, Japan
Pfizer Investigational Site
Iruma, Saitama, Japan
Japan, Tokyo
Pfizer Investigational Site
Sumida, Tokyo, Japan
Pfizer Investigational Site
Edogawa-ku, Tokyo, Japan
Pfizer Investigational Site
Setagaya-ku, Tokyo, Japan

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0531086
Study First Received:	March 2, 2007
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00443456
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Calcium, Dietary
Vascular Diseases
Essential hypertension
Amlodipine
Hypertension

Additional relevant MeSH terms:

Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Calcium Channel Blockers

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009