"As Required" Oral Sildenafil in Raynaud's Phenomenon

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether "on-demand" sildenafil is effective in the treatment of Raynaud's phenomenon.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

• Active Raynaud's Phenomenon characterized by a clinical history of primary or secondary Raynaud's Phenomenon

• At least 7 RP attacks per week on 5 or more days per week (assessed over the 2 weeks preceding inclusion)

• Patients who have dated and signed the informed consent form

• Contraception for women

Exclusion Criteria:

• Recently diagnosed RP (less than 2 months).

• Uncontrolled hypertension, diabetes mellitus, angina

• Haemodynamic instability

• Nonarteritic ischemic optic neuropathy

• Pulmonary hypertension

• Subjects currently taking sildenafil, tadalafil or vardenafil

• Subjects currently taking nitrates

• Subjects currently taking strong CYP3A inhibitors

• Pregnancy (or considering pregnancy in the next 4 months)

• Breast feeding

• Participation in another clinical trial