Effects of Vardenafil on Clinical Symptoms and Peripheral Blood Flow in Patients With Raynaud's Syndrome

• Sponsor: University of Cologne (Other)
• Overall Status: Completed
• CT.gov ID: NCT01291199
• Collaborator: (none)
• Enrollment: 57
• Location: 1
• Arms: 2
• Duration (Months): 41
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether vardenafil is effective in improving clinical symptoms and peripheral blood flow in patients with primary and secondary Raynaud phenomenon.

Condition or Disease	Intervention/Treatment	Phase
Raynaud Syndrome	Drug: vardenafil; Drug: Placebo	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Double-blind, Placebo-controlled Cross-over Study to Investigate the Effects of the Phosphodiesterase 5-inhibitor Vardenafil on Periphery Blood Flow and Clinical Symptoms of Patients With Raynaud's Syndrome
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vardenafil 10 mg bid	Drug: vardenafil; 10 mg p.o. bid for 6 weeks; Other Names: Levitra ; Drug: Placebo; Placebo p.o. 6 weeks bid
Placebo Comparator: Placebo	Drug: vardenafil; 10 mg p.o. bid for 6 weeks; Other Names: Levitra ; Drug: Placebo; Placebo p.o. 6 weeks bid

Outcome Measures

Primary Outcome Measures

1. Change in the Raynaud's Condition Score [daily for 18 weeks]

   The Raynaud's Condition Score (RCS) is a clinically validated scale used to determine the difficulty that patients experience with Raynaud's phenomenon, and is closely associated with the measures of disability and overall impact and activity of the disease.

Secondary Outcome Measures

1. Number of participants with adverse events as a Measure of Safety and Tolerability [daily for 18 weeks]

2. Digital blood flow [at baseline, one hour after drug intake and after six weeks on therapy]

   digital blood flow measured with laser doppler

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• raynaud-syndrome (primary or secondary) > 1 year duration

• age ≥ 18 years; ≤ 80 years

• informed consent

• a negative pregnancy test in women of child-bearing age

Exclusion Criteria:

• any unstable organic, psychiatric or addictive disease, which - in the opinion of the investigators - might result in an unsuccessful / unreliable participation or premature termination of the trial

• known contraindications against PDE 5-inhibitors (such as intolerance, therapy with nitrates or inhibitors of CYP3A4, etc.)

• extensive necrosis of the finger tips

• pigmentary retinopathy

• verification as a HbsAg or hepatitis C carrier

• unstable angina

• heart failure (NYHA III or IV)

• valve defects of higher degree (particularly aortic stenosis and hypertrophic obstructive cardiomyopathy)

• myocardial infarction, stroke or life-threatening cardiac arrhythmias within the last 6 months

• uncontrolled atrial fibrillation / -flutter with a heart rate > 100 bpm

• prolonged QTc-interval (> 450 msec)

• congenital long-QT-syndrome

• hypokalemia

• severe acute or chronic liver disease, which might lead to priapism (sickle cell anemia, leucemia)

• hemophilia

• active peptic ulcers

• arterial hypotension (systolic blood pressure at rest <90 mmHg) or

• arterial hypertension(systolic blood pressure at rest >170 mmHg or diastolic blood pressure at rest >110 mmHg)

• malignancy within the last 5 years (except squamous or basal cell skin cancer)

• patients with injuries of the spinal cord or central nervous system

• patients with severe chronic kidney disease (creatinin clearance < 30 ml)

• patients with mild to severe liver disease (Child-Pugh A-C)

• Age below 18 or above 80

• prohibited concomitant medication during the study:

• nitrates or other NO-donators (including amylnitrit)

• anticoagulative drugs except inhibitors of thrombocyte function

• androgens (such as testosterone) or anti-androgens

• strong inhibitors of cytochrome P4503A4:

• very potent HIV-Protease-inhibitors (ritonavir, indinavir)

• anti-mycotic like itraconazole and ketoconazole (topical applications are allowed)

• erythromycin

• grapefruit-juice or products containing grapefruit-juice

• other study medications (including placebo) up to 30 days before study inclusion

• therapy of erectile dysfunction(including sildenafil, sublingual apomorphin, MUSE®, intracavernous injections or vacuum pumps) or other therapies of erectile dysfunction within 4 weeks and during the trial period

• nebivolol

• alpha-blockers

• Calcium antagonists

• medications prolonging the QT-interval

• abnormal lab tests like:

• serum-creatinine > 3 mg/dl at visit 1

• GOT and GPT > 3 x reference limit set

• diabetes mellitus with a HbA1c > 9%

• patients who are not willing to disclaim a therapy of their erectile dysfunction with vacuum pumps, intravenous injections, sildenafil or other therapies during the trial

• severe migraine (more than once a moth during the last 6 months)

• intolerance to the study medication

• patients who are not able to understand the information and informed consent due to a mental disorder or linguistic barriers

• persons who are living in a institution directly under federal government control due to a court order

• patients who refuse to renounce drinking grapefruit juice during the trial

• women who are pregnant or lactating

• women who are not protected from a pregnancy (intake of oral contraceptives alone in insufficient; highly effective methods of birth control have to be used with a failure rate <1%; barriers: implants, intrauterine-devices (IUD´s),diaphragm, condoms, abstinence, partner is vasectomized, spermicides)

• patients who participated in other interventional studies within 30 days of study inclusion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Cologne - Heart Center	Cologne	NRW	Germany	50924

Sponsors and Collaborators

• University of Cologne

Investigators

• Principal Investigator: Stephan Rosenkranz, MD, University of Cologne

Study Documents (Full-Text)

None provided.

More Information

Publications

• Caglayan E, Huntgeburth M, Karasch T, Weihrauch J, Hunzelmann N, Krieg T, Erdmann E, Rosenkranz S. Phosphodiesterase type 5 inhibition is a novel therapeutic option in Raynaud disease. Arch Intern Med. 2006 Jan 23;166(2):231-3.

• ClinicalTrials.gov Identifier: NCT01291199
• Other Study ID Numbers: Ro-002/05; 2005-000295-41
• First Posted: Feb 8, 2011
• Last Update Posted: Feb 8, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: double-blind placebo controlled cross-over study
• Additional relevant MeSH terms: Raynaud Disease; Syndrome; Vardenafil Dihydrochloride

Study Results

No Results Posted as of Feb 8, 2011