Tadalafil for the Treatment of Raynaud's

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators propose that tadalafil will increase digital blood flow and improve the symptoms and signs of secondary Raynaud's phenomenon.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: Eli Lilly and Company
• Treatments: Tadalafil

Criteria

Inclusion Criteria:

• active Raynaud's Phenomenon

• stable disease and medication requirements over the previous 2 months

• subjects willing and able to participate in study assessments

• ability to understand and sign informed consent

• ages 18 to 65, both sexes

• a diagnosis of diffuse or limited cutaneous sclerosis, MCTD using the American College Rheumatology criteria

Exclusion Criteria:

• uncontrolled HTN, DM, unstable disease, angina or using oral nitrates

• smoking, active alcoholism, drug abuse within 5 years

• abnormal renal function

• ulnar arterial occlusive disease as shown by a positive Allen Test

• Pregnant or breast feeding or considering preg. in next 4 months

• past or present major psych. illness

• allergy or sensitivity to tadalafil

• subject unable to understand protocol or give informed consent

• part. in another study trial within 30 days

• taking sildenafil