Raynaud SyndromePhase 2/3NCT01291199
Effects of Vardenafil on Clinical Symptoms and Peripheral Blood Flow in Patients With Raynaud's Syndrome
A Phase 2/3 study testing vardenafil in people with Raynaud Syndrome, run by University of Cologne at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Raynaud Syndrome
- What is being tested?
- vardenafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2006to Apr 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Cologne - Heart Center
Cologne, North Rhine-Westphalia, 50924
About this study
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
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.
- Conditions
- Raynaud Syndrome
- Being tested
- vardenafil, Placebo
- Keywords
- double-blind placebo controlled cross-over study
- Medical subject headings
- Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vardenafilDrug
Also called Levitra
10 mg p.o. bid for 6 weeks
PlaceboDrug
Placebo p.o. 6 weeks bid
| Study group | Role | What they receive |
|---|---|---|
| Vardenafil 10 mg bid | Experimental | Not described Receives: Drug: vardenafil; Drug: Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: vardenafil; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Raynaud's Condition Score
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.
Measured: daily for 18 weeks
Secondary outcomes (2)
Number of participants with adverse events as a Measure of Safety and Tolerability
Measured: daily for 18 weeks
Digital blood flow
digital blood flow measured with laser doppler
Measured: at baseline, one hour after drug intake and after six weeks on therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startNov 2006
- Primary completionAug 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Raynaud SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Investigators
- Stephan Rosenkranz, MD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291199
- Sponsor's protocol ID
- Ro-002/05
- Other IDs
- 2005-000295-41, 2005
- Status last verified
- Jan 2011
- First submitted
- 1 Feb 2011
- Last updated
- 8 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1001/archinte.166.2.231.
PubMed 16432094
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01291199
- Acronym / sponsor ID
- Ro-002/05
- Conditions
- Raynaud Syndrome
- Keywords
- double-blind placebo controlled cross-over study
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 8 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vardenafil 10 mg bid | Experimental | Drug: vardenafil, Drug: Placebo |
| Placebo | Placebo comparator | Drug: vardenafil, Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (51 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vardenafilAlso: Levitra10 mg p.o. bid for 6 weeks | Drug | Placebo, Vardenafil 10 mg bid |
| PlaceboPlacebo p.o. 6 weeks bid | Drug | Placebo, Vardenafil 10 mg bid |
Primary outcome
Change in the Raynaud's Condition Score
Time frame: 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.
2 secondary outcomes
Number of participants with adverse events as a Measure of Safety and Tolerability
Time frame: daily for 18 weeks
Digital blood flow
Time frame: at baseline, one hour after drug intake and after six weeks on therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2011.
- Background: PubMed 16432094Caglayan 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. doi: 10.1001/archinte.166.2.231.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Rosenkranz, MD principal investigator
University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing vardenafil in people with Raynaud Syndrome, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 51 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Raynaud's Condition Score (time frame: daily for 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01291199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2011.