Collection of Blood Specimens From Patients in AL-3789 St... | NCT00691639

Studies
Collection of Blood Specimens From Patients in AL-3789 Studies for Elevated Intraocular Pressure (IOP)

NCT00691639

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Oct 1, 2009Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Open-Angle Glaucoma

Interventions

Blood Collection Only

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Aug 2009Actual

Completion Date

Not provided

First Submitted Date

Jun 3, 2008

First Submission Date that Met QC Criteria

Jun 4, 2008

First Posted Date

Jun 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2009

Last Update Posted Date

Oct 1, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to obtain blood samples from patients who are or were participants in any Alcon AL-3789 clinical trial. Association will be conducted to search for genetic markers in patients with glaucoma or ocular hypertension.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients who are or were participants in any Alcon AL-3789 study.	Other: Blood Collection Only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood Collection Only	Other	Blood Collection Only	1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient must be currently or previously enrolled in Alcon clinical study and received AL-3789

Exclusion Criteria:

Age related

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who received anecortave acetate treatment

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alcon Call Center		Fort Worth	Texas	76134	United States

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided