Status:
COMPLETED
Tadalafil for the Treatment of Raynaud's
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Raynaud
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The investigators propose that tadalafil will increase digital blood flow and improve the symptoms and signs of secondary Raynaud's phenomenon.
Detailed Description
The primary goal of our study is to decrease the frequency, duration and severity of vasospastic attacks in patients with secondary Raynaud's. The secondary goal is to document increased blood flow an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00822354
Start Date
September 1 2008
End Date
April 1 2010
Last Update
December 4 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611