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Tadalafil for the Treatment of Raynaud's

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Anne Laumann, Northwestern University
ClinicalTrials.gov Identifier:
NCT00822354
First received: May 31, 2008
Last updated: February 14, 2013
Last verified: February 2013

May 31, 2008
February 14, 2013
September 2008
February 2010   (final data collection date for primary outcome measure)
Raynaud's condition score(RCS) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Raynaud's condition score(RSC) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00822354 on ClinicalTrials.gov Archive Site
Digital blood pressure [ Time Frame: every 2 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Tadalafil for the Treatment of Raynaud's
Tadalafil for the Treatment of Secondary Raynaud's Phenomenon

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

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 and lessened capillary dysfunction in these patients. Both of these goals are to be achieved using a course of treatment with Tadalafil.We anticipate a decrease in the frequency, duration and severity of Raynaud's attacks. Improved digital blood flow and digital blood pressures, and a decrease in digital capillary dysfunction.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Raynaud
Drug: Tadalafil
Subjects will be randomized to receive either tadalafil for the first month followed by placebo or placebo for the first month and followed by tadalafil
Other Name: Cialis
  • Experimental: 1
    Subjects will receive tadalafil 20mg every other day for the first month, and then placebo for the second month.
    Intervention: Drug: Tadalafil
  • Experimental: 2
    Subjects will receive placebo for the first month, and tadalafil 20mg orally every other day for the second month.
    Intervention: Drug: Tadalafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
April 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00822354
STU1199
No
Anne Laumann, Northwestern University
Northwestern University
Eli Lilly and Company
Principal Investigator: Anne Laumann, MBChB, MRCP Northwestern University
Northwestern University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP