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NCT02114203 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Study Of PF-04447943, Co-Administered With And Without Hydroxyurea, In Subjects With Stable Sickle Cell Disease
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT02114203: Completed Phase 1 study, sponsored by Pfizer.
NCT02114203 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02114203, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study is being conducted to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of an investigational drug, PF-04447943, in subjects with stable sickle cell disease with and without co-administration with hydroxyurea. This study will also aid in selecting the doses for future studies and evaluation of substances in the blood which may help access the effectiveness of the drug.
Primary Outcome
Number of participants with changes from baseline in vital signs meeting the following criteria is presented: (1) maximum increase from baseline in supine systolic blood pressure (SBP) \>=30 millimeters of mercury (mmHg); (2) maximum increase from baseline in supine diastolic blood pressure (DBP) \>=20 mmHg; (3) maximum decrease from baseline in supine SBP \>=30 mmHg; and (4) maximum decrease from baseline in supine DBP \>=20 mmHg.
Interventions
- DRUG PDE9i
- DRUG placebo for PDE9i
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-12 |
| Est. Completion | 2016-09 |
| Phase | Phase 1 |
What the finished NCT02114203 record still lists
NCT02114203 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which PDE9i is the first listed.
NCT02114203 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02114203 about?
NCT02114203 is a clinical study titled "Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Study Of PF-04447943, Co-Administered With And Without Hydroxyurea, In Subjects With Stable Sickle Cell Disease". This study is being conducted to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of an investigational drug, PF-04447943, in subjects with stable sickle cell disease with and without co-administration with hydroxyurea. This study will also aid in selecting the doses for future...
What is the current status of trial NCT02114203?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2014-12. Estimated completion is 2016-09.
What interventions are being tested in trial NCT02114203?
The interventions under investigation include: PDE9i (DRUG), placebo for PDE9i (DRUG).
Who is sponsoring clinical trial NCT02114203?
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 NCT02114203's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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