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Treatment for Completers of the Study B7A-MC-MBCM

Primary Purpose

Diabetic Retinopathy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ruboxistaurin
Sponsored by
Chromaderm, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients that completed Month 36 (Visit 15) of the study B7A-MC-MBCM, and the investigator believes he/she would benefit from ruboxistaurin treatment. Exclusion Criteria: Patients that discontinued from the study B7A-MC-MBCM and/or the investigator does not believe he/she would benefit from ruboxistaurin treatment.

Sites / Locations

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ruboxistaurin

Arm Description

Outcomes

Primary Outcome Measures

Sustained Moderate Visual Loss (SMVL)
The number of participants who experienced SMVL in at least 1 diabetic retinopathy (DR) study eye. SMVL was a ≥15-letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that was sustained for the last 6 months of the study. Best-corrected ETDRS VA was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly).

Secondary Outcome Measures

Vision Loss
The number of participants whose best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) in at least 1 diabetic retinopathy (DR) study eye decreased by 15-letters or less from the conclusion of Study MBCM to the start of Study MBDV, 6 to 18 months later. Best-corrected ETDRS VA was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly).
Sustained Moderate Vision Loss (SMVL), Long Term
The number of participants who experienced SMVL, long term, in at least 1 diabetic retinopathy (DR) study eye. Long term SMVL was a ≥15-letter decrease from Study MBCM baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that was sustained for the last 6 months of Study MBDV. VA was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly).
Number of Participants With a Modified Sustained Moderate Vision Loss (mSMVL) Event by Time Interval
An mSMVL event was defined as a ≥15-letter decrease from Study MBDV baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) during any 6-month period, not just the last 6 months of the study. An mSMVL event was the first occurrence of an mSMVL in a participant, and the time at which the mSMVL began was used as the time of the event for the analysis. VA was measured at 4 meters (m) using an eye chart with 5 letters per row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed.
Visual Acuity
Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly). A higher score represented better VA.
Number of Participants Receiving Treatment With Focal/Grid Photocoagulation
Number of Participants Receiving Treatment With Panretinal Photocoagulation

Full Information

First Posted
December 15, 2005
Last Updated
August 25, 2016
Sponsor
Chromaderm, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00266695
Brief Title
Treatment for Completers of the Study B7A-MC-MBCM
Official Title
Open-Label Treatment for Patients Completing Study B7A-MC-MBCM
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chromaderm, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To provide ruboxistaurin treatment to patients who completed the B7A-MC-MBCM study (NCT00604383), and who are felt by the investigator to have the potential to benefit from the ruboxistaurin treatment. Patients must be off study drug for 6 to 18 months from completion of B7A-MC-MBCM before beginning B7A-MC-MBDV. Additional data will be gathered to determine the long-term safety and effect of ruboxistaurin on vision.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ruboxistaurin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ruboxistaurin
Other Intervention Name(s)
LY 333531, Arxxant
Intervention Description
32-milligram (mg) tablet, orally, once daily (QD) for up to 2 years.
Primary Outcome Measure Information:
Title
Sustained Moderate Visual Loss (SMVL)
Description
The number of participants who experienced SMVL in at least 1 diabetic retinopathy (DR) study eye. SMVL was a ≥15-letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that was sustained for the last 6 months of the study. Best-corrected ETDRS VA was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly).
Time Frame
Baseline, 18 months up to 24 months
Secondary Outcome Measure Information:
Title
Vision Loss
Description
The number of participants whose best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) in at least 1 diabetic retinopathy (DR) study eye decreased by 15-letters or less from the conclusion of Study MBCM to the start of Study MBDV, 6 to 18 months later. Best-corrected ETDRS VA was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly).
Time Frame
End of Study MBCM to the beginning of Study MBDV, approximately 6 to 18 months
Title
Sustained Moderate Vision Loss (SMVL), Long Term
Description
The number of participants who experienced SMVL, long term, in at least 1 diabetic retinopathy (DR) study eye. Long term SMVL was a ≥15-letter decrease from Study MBCM baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that was sustained for the last 6 months of Study MBDV. VA was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly).
Time Frame
Baseline in Study MBCM, 18 months up to 24 months in Study MBDV (for a total of 75 up to 87 months of SMVL, long term)
Title
Number of Participants With a Modified Sustained Moderate Vision Loss (mSMVL) Event by Time Interval
Description
An mSMVL event was defined as a ≥15-letter decrease from Study MBDV baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) during any 6-month period, not just the last 6 months of the study. An mSMVL event was the first occurrence of an mSMVL in a participant, and the time at which the mSMVL began was used as the time of the event for the analysis. VA was measured at 4 meters (m) using an eye chart with 5 letters per row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed.
Time Frame
Baseline up to 6 months, 6 months up to 12 months, 12 months up to 18 months, 18 months up to 24 months, and 24 months up to 30 months
Title
Visual Acuity
Description
Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If <20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly). A higher score represented better VA.
Time Frame
Month 24
Title
Number of Participants Receiving Treatment With Focal/Grid Photocoagulation
Time Frame
Baseline up to Month 24
Title
Number of Participants Receiving Treatment With Panretinal Photocoagulation
Time Frame
Baseline up to Month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients that completed Month 36 (Visit 15) of the study B7A-MC-MBCM, and the investigator believes he/she would benefit from ruboxistaurin treatment. Exclusion Criteria: Patients that discontinued from the study B7A-MC-MBCM and/or the investigator does not believe he/she would benefit from ruboxistaurin treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Beutner
Organizational Affiliation
Chromaderm, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Wheaton
State/Province
Illinois
ZIP/Postal Code
60187
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment for Completers of the Study B7A-MC-MBCM

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