DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma, Primary Open Angle (POAG); Ocular Hypertension

Intervention: Xalacom (KP2035) (Drug); Xalatan (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

This study will examine the efficacy and safety of Xalacom comparing with those of Xalatan in Japanese patients with POAG or OH.

Clinical Details

Official title: A 8-Week, Randomized, Double-Masked, Parallel Group, Phase III Study Comparing The Efficacy And Safety Of Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Change of Intraocular Pressure (IOP) From Baseline to Week 8

Secondary outcome:

Change of IOP From Baseline to Week 4

Percent Change of IOP From Baseline to Week 8

Number of Subjects With an IOP of <=15 mmHg at Week 8

Number of Subjects With an IOP of <=16 mmHg at Week 8

Number of Subjects With an IOP of <=17 mmHg at Week 8

Number of Subjects With an IOP of <=18 mmHg at Week 8

Number of Subjects With an IOP Reduction of >=2 mmHg From Baseline to Week 8

Number of Subjects With an IOP Reduction of >=3 mmHg From Baseline to Week 8

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Intraocular pressure is 18 mmHg or more at baseline after treatment with Xalatan for

4 weeks or more. Exclusion Criteria:

- History of no-response to timolol

- History of trabeculectomy

- History of other ocular surgery including ALT, SLT,and trabeculotomy within 6 months

Locations and Contacts

Pfizer Investigational Site, Fujuoka 812-0011, Japan

Pfizer Investigational Site, Fukuoka 814-0133, Japan

Pfizer Investigational Site, Fukuoka 812-0036, Japan

Pfizer Investigational Site, Fukuoka 810-0002, Japan

Pfizer Investigational Site, Gifu 501-1194, Japan

Pfizer Investigational Site, Hiroshima 734-8551, Japan

Pfizer Investigational Site, Niigata 951-8122, Japan

Pfizer Investigational Site, Osaka 537-0025, Japan

Pfizer Investigational Site, Osaka 557-0044, Japan

Pfizer Investigational Site, Osaka, Japan

Pfizer Investigational Site, Shizuoka 420-0833, Japan

Pfizer Investigational Site, Sugita, Japan

Pfizer Investigational Site, Ichinomiya, Aichi 491-0837, Japan

Pfizer Investigational Site, Ichinomiya, Aichi 491-0858, Japan

Pfizer Investigational Site, Nagoya, Aichi 460-0011, Japan

Pfizer Investigational Site, Nagoya, Aichi 466-0054, Japan

Pfizer Investigational Site, Nagoya, Aichi 467-0806, Japan

Pfizer Investigational Site, Narashino, Chiba 275-0016, Japan

Pfizer Investigational Site, Sapporo, Hokkaido 001-0016, Japan

Pfizer Investigational Site, Sapporo, Hokkaido 001-0039, Japan

Pfizer Investigational Site, Sapporo, Hokkaido 004-0041, Japan

Pfizer Investigational Site, Sapporo, Hokkaido 062-0020, Japan

Pfizer Investigational Site, Koube, Hyogo 650-0017, Japan

Pfizer Investigational Site, Kanazawa, Ishikawa 920-0934, Japan

Pfizer Investigational Site, Fujisawa, Kanagawa 251-0052, Japan

Pfizer Investigational Site, Kamakura, Kanagawa 248-0035, Japan

Pfizer Investigational Site, Sagamihara, Kanagawa 228-0806, Japan

Pfizer Investigational Site, Yokohama, Kanagawa 222-0011, Japan

Pfizer Investigational Site, Sapporo, Kokkaido 003-0062, Japan

Pfizer Investigational Site, Uji, Kyoto 611-0043, Japan

Pfizer Investigational Site, Miyakonojo, Miyazaki 885-0051, Japan

Pfizer Investigational Site, Kumagaya, Saitama 360-0843, Japan

Pfizer Investigational Site, Tokorozawa, Saitama 359-1116, Japan

Pfizer Investigational Site, Fuji, Shizuoka 416-0952, Japan

Pfizer Investigational Site, Fuji, Shizuoka 419-0204, Japan

Pfizer Investigational Site, Mishima, Shizuoka 411-0824, Japan

Pfizer Investigational Site, Susono, Shizuoka 410-1102, Japan

Pfizer Investigational Site, Bunkyo-ku, Tokyo 113-8655, Japan

Pfizer Investigational Site, Chiyoda-ku, Tokyo 101-0062, Japan

Pfizer Investigational Site, Chiyoda, Tokyo 102-8161, Japan

Pfizer Investigational Site, Hachioji, Tokyo 192-0046, Japan

Pfizer Investigational Site, Hamura, Tokyo 205-0001, Japan

Pfizer Investigational Site, Katsushika-ku, Tokyo 125-0041, Japan

Pfizer Investigational Site, Kiyose, Tokyo 204-0021, Japan

Pfizer Investigational Site, Koto-ku, Tokyo 136-0076, Japan

Pfizer Investigational Site, Meguro-ku, Tokyo 153-0043, Japan

Pfizer Investigational Site, Meguro, Tokyo 152-0032, Japan

Pfizer Investigational Site, Musashino, Tokyo 180-0022, Japan

Pfizer Investigational Site, Musashino, Tokyo 180-0004, Japan

Pfizer Investigational Site, Ota-ku, Tokyo 144-052, Japan

Pfizer Investigational Site, Setagaya, Tokyo 157-0066, Japan

Pfizer Investigational Site, Shinjuku, Tokyo 160-0004, Japan

Pfizer Investigational Site, Tachikawa, Tokyo 190-0003, Japan

Pfizer Investigational Site, Taito-ku, Tokyo 110-015, Japan

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: November 2006
Last updated: August 3, 2009

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017