"As Required" Oral Sildenafil in Raynaud's Phenomenon

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Raynaud's Phenomenon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sildenafil 80 mg

Group Type EXPERIMENTAL

Sildenafil 80 mg

Intervention Type DRUG

Sildenafil 40 mg

Group Type EXPERIMENTAL

Sildenafil 40 mg

Intervention Type DRUG

Placebo

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Sildenafil 40 mg

Intervention Type DRUG

Sildenafil 80 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No