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A Trial Of Azithromycin SR For The Treatment Of Mild To Moderate Community Acquired Pneumonia In Japanese Adults

NCT ID: NCT00360295

Last Updated: 2008-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-05-31

Brief Summary

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To evaluate the clinical efficacy and safety in patients with mild or moderate community-acquired pneumonia receiving a dose of 2 g of azithromycin in the SR formulation.

Detailed Description

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Conditions

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Pneumonia, Community-Acquired

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Azithromycin SR

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who were diagnosed as mild or moderate in severity by the classification of pneumonia "Clinical evaluation methods for new antimicrobial agents to treat respiratory infections: Report of the Committee for the Respiratory System, Japan Society of Chemotherapy (established in 2000)".

Exclusion Criteria

* Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases. ("Severe" assessed by the Severity of underlying diseases and complications of "Clinical evaluation methods for new antimicrobial agents to treat respiratory infections (draft)" by the Japan Society of Chemotherapy (1997)).
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Asahi, Chiba, Japan

Site Status

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

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Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

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Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

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Pfizer Investigational Site

Higashi, Fukuoka, Japan

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Pfizer Investigational Site

Kasuya-gun, Fukuoka, Japan

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Pfizer Investigational Site

Munakata, Fukuoka, Japan

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Pfizer Investigational Site

Nishiku, Fukuoka, Japan

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Pfizer Investigational Site

Isesaki, Gunma, Japan

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Pfizer Investigational Site

Maebashi, Gunma, Japan

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Pfizer Investigational Site

Asahikawa, Hokkaido, Japan

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Pfizer Investigational Site

Asahikawa, Hokkaido, Japan

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Asahikawa, Hokkaido, Japan

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Pfizer Investigational Site

Asahikawa, Hokkaido, Japan

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Pfizer Investigational Site

Kamikawa-gun, Hokkaido, Japan

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Pfizer Investigational Site

Sapporo, Hokkaido, Japan

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Pfizer Investigational Site

Teine, Hokkaido, Japan

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Pfizer Investigational Site

Hitachi, Ibaraki, Japan

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Pfizer Investigational Site

Hitachi-Naka, Ibaraki, Japan

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Pfizer Investigational Site

Kasama, Ibaraki, Japan

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Moriya, Ibaraki, Japan

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Toride, Ibaraki, Japan

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Pfizer Investigational Site

Tsuchiura, Ibaraki, Japan

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Pfizer Investigational Site

Marugame, Kagawa-ken, Japan

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Pfizer Investigational Site

Yokohama, Kanagawa, Japan

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Pfizer Investigational Site

Yokosuka, Kangawa, Japan

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Pfizer Investigational Site

Emukae, Kitamatsuura, Nagasaki, Japan

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Pfizer Investigational Site

Hirase-cho, Sasebo,, Nagasaki, Japan

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Pfizer Investigational Site

Nagasaki, Nagasaki, Japan

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Shigesato-cho, Nagasaki, Nagasaki, Japan

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Pfizer Investigational Site

Ohte-machi, Oita City, Oita Prefecture, Japan

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Pfizer Investigational Site

Oita City, Oita, Oita Prefecture, Japan

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Pfizer Investigational Site

Ōita, Oita Prefecture, Japan

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Pfizer Investigational Site

Ōita, Oita Prefecture, Japan

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Pfizer Investigational Site

Ōita, Oita Prefecture, Japan

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Pfizer Investigational Site

Tanaka-machi, Oita, Oita Prefecture, Japan

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Pfizer Investigational Site

Yufu, Oita Prefecture, Japan

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Pfizer Investigational Site

Naha, Okinawa, Japan

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Pfizer Investigational Site

Nakagami-gun, Okinawa, Japan

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Pfizer Investigational Site

Okinawa, Okinawa, Japan

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Pfizer Investigational Site

Shimajiri-gun, Okinawa, Japan

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Pfizer Investigational Site

Daitō, Osaka, Japan

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Pfizer Investigational Site

Katano, Osaka, Japan

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Pfizer Investigational Site

Kita-ku, Osaka, Japan

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Pfizer Investigational Site

Koshigaya, Saitama, Japan

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Pfizer Investigational Site

Kiyose, Tokyo, Japan

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Pfizer Investigational Site

Nakano City, Tokyo, Japan

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Pfizer Investigational Site

Ōme, Tokyo, Japan

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Pfizer Investigational Site

Setagaya City, Tokyo, Japan

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Pfizer Investigational Site

Setagaya City, Tokyo, Japan

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Pfizer Investigational Site

Shinagawa, Tokyo, Japan

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Pfizer Investigational Site

Sumida City, Tokyo, Japan

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Pfizer Investigational Site

Yamagata, Yamagata, Japan

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Pfizer Investigational Site

Yonezawa, Yamagata, Japan

Site Status

Countries

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Japan

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661174&StudyName=A%20Trial%20Of%20Azithromycin%20SR%20For%20The%20Treatment%20Of%20Mild%20To%20Moderate%20Community%20Acquired%20Pneumonia%20In%20Japan%20Adults

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Other Identifiers

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A0661174

Identifier Type: -

Identifier Source: org_study_id