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A Placebo Controlled Study of MR901 (Talaporfin Sodium Sodium + a Drug-activating Device) for the Relief of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02326454
Recruitment Status : Completed
First Posted : December 29, 2014
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
Mundipharma Research Limited
Information provided by (Responsible Party):
Light Sciences Oncology

Information on FDAAA 801 Violations
More Information: Notices of Noncompliance [FDA]
Table of FDAAA 801 Violation Notices
Available on ClinicalTrials.gov Issued by FDA Study Record Submitted Notice Type FDAAA 801 Notice
December 7, 2023 November 22, 2023 August 2, 2023 Issues in letter addressed; confirmed by FDA. The responsible party has responded, and this matter was resolved administratively.
July 31, 2023 July 19, 2023 August 6, 2018 Violation Identified by FDA Failure to Submit