CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
PDE9i +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02114203
NCT02114203Phase 1Completed

A Phase 1b, Randomized, Double-blind (Sponsor Open), Placebo Controlled Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Pf 04447943, Co-administered With And Without Hydroxyurea, In Subjects With Stable Sickle Cell Disease

Pfizer·interventional·Posted Apr 15, 2014·Updated Dec 14, 2017

In Brief

A Phase 1 clinical trial evaluating PDE9i and placebo for PDE9i for Phase 1 Sickle Cell. Completed, enrolled 30 participants across 23 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Italy, Netherlands, United Kingdom, United States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 15, 2014
Enrollment StartDec 1, 2014
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.2 years ago

Interventions

PDE9idrug

oral dose, every 12 hours for 28 days

PDE9idrug

oral dose, every 12 hours for 28 days

placebo for PDE9idrug

oral dose, every 12 hours for 28 days

PDE9idrug

oral dose, every 12 hours for 28 days