Raynaud DiseasePhase 2DIGITNCT01926847
Digital Flow Enhancement in Raynaud's Phenomenon With an sGC (Soluble Guanylate Cyclase) Stimulator
A Phase 2 study testing Riociguat (Adempas, BAY63-2521) in people with Raynaud Disease, run by Bayer at 1 site in Germany.
Trial summary
Patients with Raynaud's phenomenon suffer from painful attacks triggered by stress or cold causing acute lowering of blood flow through the digits. In this trial the safety and efficacy as well as the effect of one dose of the sGC stimulator Riociguat on digital blood flow will be measured during a cold exposure test… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Raynaud Disease
- What is being tested?
- Riociguat (Adempas, BAY63-2521)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Jun 2014
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from Raynaud's phenomenon diagnosed at least ≥1 year before beginning of the study of the following origin:
- idiopathic (primary)
- limited cutaneous Scleroderma associated
- diffuse cutaneous Scleroderma associated
- mixed connective tissue disease associated
Who cannot join
- Patients taking medication interfering with the digital flow measurement such as calcium channel blockers (CCB), phosphodiesterase 5 (PDE5) inhibitors, endothelin receptor antagonists (ERA), Nitrates
- Smokers
- Systolic blood pressure (SBP) below 105mmHg at rest
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose, Double-blind, Placebo-controlled, Single Center, Randomized Cross-over Study to Investigate Safety, Tolerability, Pharmacodynamics and Pharmacokinetic Properties of BAY63-2521 After Oral Dosing in 20 Patients With Raynaud's Phenomenon (RP)
Patients with Raynaud's phenomenon suffer from painful attacks triggered by stress or cold causing acute lowering of blood flow through the digits. In this trial the safety and efficacy as well as the effect of one dose of the sGC stimulator Riociguat on digital blood flow will be measured during a cold exposure test in patients suffering from Raynaud's phenomenon. Measurements of two periods will be compared: in one period the patient will be given active drug and in the other period a placebo.
- Conditions
- Raynaud Disease
- Being tested
- Riociguat (Adempas, BAY63-2521), Placebo
- Keywords
- Digital ischemia, Raynaud's phenomenon
- Medical subject headings
- Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riociguat (Adempas, BAY63-2521)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Riociguat+Placebo | Experimental | Randomization order 1: first single oral dose of 2 mg BAY63-2521, then matching placebo Receives: Drug: Riociguat (Adempas, BAY63-2521); Drug: Placebo |
| Placebo+Riociguat | Experimental | Randomization order 2: first matching placebo, then single oral dose of 2 mg BAY63-2521 Receives: Drug: Riociguat (Adempas, BAY63-2521); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety and tolerability
Measured: 5 weeks
Blood pressure
Measured: 5 weeks
Pulse rate
Measured: 5 weeks
Incidence of participants showing changes during clinical laboratory and hematology assessment
Measured: From baseline to 5 weeks
Plasma concentration at 2 h after riociguat administration
Measured: After 2 hours
Placebo corrected change in digital blood flow at room temperature, measured by Laser Doppler Perfusion Imaging
Measured: At baseline and after 2h
Placebo corrected change in digital blood flow during cold exposure, measured by Laser Doppler Perfusion Imaging
Measured: At baseline and after 2h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Raynaud DiseaseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926847
- Sponsor's protocol ID
- 16787
- Other IDs
- 2013-001899-38
- Acronym
- DIGIT
- Status last verified
- Jun 2014
- First submitted
- 19 Aug 2013
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose, Double-blind, Placebo-controlled, Single Center, Randomized Cross-over Study to Investigate Safety, Tolerability, Pharmacodynamics and Pharmacokinetic Properties of BAY63-2521 After Oral Dosing in 20 Patients With Raynaud's Phenomenon (RP)
- ClinicalTrials.gov ID
- NCT01926847
- Acronym / sponsor ID
- DIGIT / 16787
- Conditions
- Raynaud Disease
- Keywords
- Digital ischemia, Raynaud's phenomenon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 21 Aug 2013 (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.
Patients with Raynaud's phenomenon suffer from painful attacks triggered by stress or cold causing acute lowering of blood flow through the digits. In this trial the safety and efficacy as well as the effect of one dose of the sGC stimulator Riociguat on digital blood flow will be measured during a cold exposure test in patients suffering from Raynaud's phenomenon. Measurements of two periods will be compared: in one period the patient will be given active drug and in the other period a placebo.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Riociguat+Placebo | Experimental | Drug: Riociguat (Adempas, BAY63-2521), Drug: PlaceboRandomization order 1: first single oral dose of 2 mg BAY63-2521, then matching placebo |
| Placebo+Riociguat | Experimental | Drug: Riociguat (Adempas, BAY63-2521), Drug: PlaceboRandomization order 2: first matching placebo, then single oral dose of 2 mg BAY63-2521 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients suffering from Raynaud's phenomenon diagnosed at least ≥1 year before beginning of the study of the following origin:
Key exclusion criteria (3 listed)
- Patients taking medication interfering with the digital flow measurement such as calcium channel blockers (CCB), phosphodiesterase 5 (PDE5) inhibitors, endothelin receptor antagonists (ERA), Nitrates
- Smokers
- Systolic blood pressure (SBP) below 105mmHg at rest
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 |
|---|---|---|
| Riociguat (Adempas, BAY63-2521) | Drug | Placebo+Riociguat, Riociguat+Placebo |
| Placebo | Drug | Placebo+Riociguat, Riociguat+Placebo |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 5 weeks
Blood pressure
Time frame: 5 weeks
Pulse rate
Time frame: 5 weeks
Incidence of participants showing changes during clinical laboratory and hematology assessment
Time frame: From baseline to 5 weeks
Plasma concentration at 2 h after riociguat administration
Time frame: After 2 hours
Placebo corrected change in digital blood flow at room temperature, measured by Laser Doppler Perfusion Imaging
Time frame: At baseline and after 2h
Placebo corrected change in digital blood flow during cold exposure, measured by Laser Doppler Perfusion Imaging
Time frame: At baseline and after 2h
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 16 Jun 2014.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Riociguat (Adempas, BAY63-2521) in people with Raynaud Disease, run by Bayer 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 5 inclusion and 3 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 16 Jun 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Number of participants with adverse events as a measure of safety and tolerability (time frame: 5 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2014.