Phase 2
N=243
PF-00489791 For The Treatment Of Raynaud's
Raynaud's Disease · Peripheral Vascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT01090492 ↗Enrolled (actual)
243
Serious AEs
0.2%
Results posted
May 2018
Primary outcome: Primary: Change From Baseline in Mean Raynaud's Condition Score (RCS) at Week 4 — 3.04; 2.90; 2.98; 3.14 units on a scale — p=0.6513
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PF-00489791 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Raynaud's Condition Score (RCS) at Week 4 |
3.04; 2.90; 2.98; 3.14; 2.53; 2.97 | 0.6513 |
| SECONDARY Change From Baseline in the Number of Raynaud's Attacks at Week 1, 2, 3 and 4 |
22.06; 16.31; 20.19; 22.80; 23.70; 23.08 | 0.9504 |
| SECONDARY Change From Baseline in Mean Duration of Raynaud's Attacks at Week 4 |
17.69; 22.23; 19.61; 19.37; 19.07; 19.91 | 0.7900 |
| SECONDARY Change From Baseline in the Mean Raynaud's Pain Score at Week 1, 2, 3 and 4 |
2.84; 2.78; 2.80; 3.33; 2.54; 3.10 | 0.5909 |
| SECONDARY Number of Participants With Decrease From Baseline in Digital Ulcers at Day 14 and 28: Secondary Raynaud's Phenomenon Cohort |
10; 7; 16; 7; 1; 6 | — |
| SECONDARY Plasma Concentration of PF-00489791 and Its Metabolites |
0.0058; NA; NA; NA; 0.1523; 0.5907 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities |
2; 4; 14; 5; 13; 10 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Vital Signs and Orthostatic Blood Pressure Measurements |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormal Electrocardiogram (ECG) Values |
0; 0; 0; 0; 0; 0 | — |
Summary
The investigators propose that once daily administration of PF-00489791, a phosphodiesterase inhibitor, will reduce vasospasm and improve symptoms and signs associated with Primary and Secondary Raynaud's Phenomenon.
Eligibility Criteria
Inclusion Criteria
- Active Raynaud's Phenomenon
- Stable disease and medication requirements over the previous two months
- For Secondary Raynaud's Phenomenon subjects, a diagnosis of scleroderma using the American College of Rheumatology criteria or by the presence of at least 3/5 features of CREST syndrome
- both sexes
Exclusion Criteria
- Uncontrolled hypertension, diabetes mellitus, angina, or using oral nitrates
- Smoking within 3 months or smoking cessation using nicotine products
- Subjects currently taking sildenafil, tadalafil or vardenafil
- Subjects with ulnar arterial occlusive disease as shown by a modified Allen test
- Pregnant or breast feeding or considering pregnancy in next 4 months
- Participation in trial for investigational drug within 30 days
Data sourced from ClinicalTrials.gov (NCT01090492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.