"As Required" Oral Sildenafil in Raynaud's Phenomenon (PROFIL)

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Raynaud's Phenomenon

Treatments: Drug: Sildenafil 80 mg; Drug: Sildenafil 40 mg; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02050360

12G01 (Other Identifier)

DCIC/12/26

2013-000014-38 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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41 participants in 3 patient groups, including a placebo group

Sildenafil 80 mg

Experimental group

Description:

Sildenafil 80 mg

Treatment:

Drug: Sildenafil 80 mg

Sildenafil 40 mg

Experimental group

Description:

Sildenafil 40 mg

Treatment:

Drug: Sildenafil 40 mg

Placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo