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Open-Label Extension of the Phase III Study With Tramiprosate (3APS) in Patients With Mild to Moderate Alzheimer's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Bellus Health Inc.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Bellus Health Inc
ClinicalTrials.gov Identifier:
NCT00314912
First received: April 13, 2006
Last updated: July 13, 2007
Last verified: July 2007

April 13, 2006
July 13, 2007
May 2006
Not Provided
To evaluate the long-term safety of Tramiprosate (3APS).
Same as current
Complete list of historical versions of study NCT00314912 on ClinicalTrials.gov Archive Site
To provide additional long-term data on the efficacy of Tramiprosate (3APS).
Same as current
Not Provided
Not Provided
 
Open-Label Extension of the Phase III Study With Tramiprosate (3APS) in Patients With Mild to Moderate Alzheimer's Disease
An Open-Label Extension of the Phase III Study CL-758007 With Tramiprosate (3APS) in Patients With Alzheimer's Disease

The purpose of this Phase III open-label extension study is to evaluate the long-term safety of Tramiprosate (3APS) in patients with mild to moderate Alzheimer’s disease.

Duration of treatment: 12 months. Patients who complete the Phase III clinical trial will be offered the opportunity to receive Tramiprosate (3APS) in an open-label extension study

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer's Disease
Drug: Tramiprosate (3APS)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
650
Not Provided
Not Provided

Inclusion Criteria:

  • The patient must have successfully completed the full 78-week duration of the double-blind CL-758007 study.
  • Male or female (age 50 years and older): Female must be of non-childbearing potential (i.e. surgically sterilized or at least 2 years post-menopausal).
  • Patient must be living in the community with a reliable caregiver. Participant living in an assisted living facility may be included if study medication intake is supervised and participant has a reliable caregiver.
  • The patient must be presenting a reasonably good nutritional status.
  • Signed inform consent from the patient or legal representative.

Exclusion Criteria:

Patients will not be eligible to participate in the study if they meet any of the following criteria:

  • The patient participates in another drug trial during the study.
  • The patient with a clinically significant and/or uncontrolled condition or other significant medical disease.
  • The patient is unable to swallow medication tablets.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00314912
CL-758017
Not Provided
Not Provided
Bellus Health Inc
Not Provided
Not Provided
Bellus Health Inc
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP