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NCT00838110 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 742
- Enrollment target
NCT00838110: Completed Phase 3 study, sponsored by Pfizer.
NCT00838110 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 742 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00838110, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 742 participants
- Enrollment target
Study Summary
This is a multi-center, randomized, double-blind placebo-controlled safety study conducted in 2 study cohorts. In Cohort 1, subjects with Alzheimer's disease (n=250) will receive Dimebon 20 mg or placebo TID for 26 weeks. In Cohort 2 AD subjects (n=500) will be treated with Dimebon 20 mg or placebo TID for 12 weeks After completion of the randomized portion of the study, subjects in both Cohorts will have the opportunity to enroll in a Dimebon open label extension study.
Primary Outcome
Abnormal clinically significant vital signs included absolute systolic blood pressure (BP) values: less than (\<) 90 millimeter of mercury (mmHg), maximum increase or decrease of greater than or equal to (\>=) 30 mmHg from baseline; absolute diastolic BP value: \<50 mmHg, maximum increase or decrease of \>=20 mmHg from baseline; absolute heart rate values: \>120 beats per minute (bpm).
Interventions
- DRUG Placebo
- DRUG Dimebon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 742 participants |
| Start Date | 2009-02 |
| Est. Completion | 2010-01 |
| Phase | Phase 3 |
What the finished NCT00838110 record still lists
NCT00838110 is an interventional study that assigns participants to a tested intervention. The registered 742 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00838110 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00838110 about?
NCT00838110 is a clinical study titled "A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease". This is a multi-center, randomized, double-blind placebo-controlled safety study conducted in 2 study cohorts. In Cohort 1, subjects with Alzheimer's disease (n=250) will receive Dimebon 20 mg or placebo TID for 26 weeks. In Cohort 2 AD subjects (n=500) will be treated with Dimebon 20 mg or placebo ...
What is the current status of trial NCT00838110?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 742 participants. The study started on 2009-02. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00838110?
The interventions under investigation include: Placebo (DRUG), Dimebon (DRUG).
Who is sponsoring clinical trial NCT00838110?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00838110's enrollment target sits among peer trials
742 476th of 2000 higher than 1,525 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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