Hypertension, PulmonaryPhase 2DILATENCT01172756
A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Diastolic Dysfunction
A Phase 2 study testing Riociguat (BAY63-2521) in people with Hypertension, Pulmonary and Ventricular Dysfunction, Left, run by Bayer at 7 sites in 3 countries.
Trial summary
The aim of this study is to assess whether single oral doses of Riociguat safely improve the cardiovascular function in patients with pulmonary hypertension associated with left ventricular diastolic dysfunction Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypertension, Pulmonary, Ventricular Dysfunction, Left
- What is being tested?
- Riociguat (BAY63-2521)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Jul 2010to Oct 2012
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients with symptomatic pulmonary hypertension due to left ventricular diastolic dysfunction
Who cannot join
- Types of pulmonary hypertension other than group 2.2 of Dana Point Classification
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Austria5 sites
Study site
Graz, Styria, 8020
Study site
Graz, Styria, 8036
Study site
Linz, Upper Austria, 4010
Study site
Salzburg, 5020
Study site
Vienna, State of Vienna, 1090
About this study
Official title: Acute Hemodynamic Effects of Riociguat (BAY63-2521) in Patients With Pulmonary Hypertension Associated With Diastolic Heart Failure: A Randomized, Double-blind, Placebo-controlled, Single-dose Study in Three Ascending Dose Cohorts
The aim of this study is to assess whether single oral doses of Riociguat safely improve the cardiovascular function in patients with pulmonary hypertension associated with left ventricular diastolic dysfunction
- Being tested
- Riociguat (BAY63-2521), Placebo
- Keywords
- Pulmonary Hypertension, Left ventricular dysfunction
- Medical subject headings
- Hypertension, Pulmonary, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riociguat (BAY63-2521)Drug
0.5 mg single oral dose
Riociguat (BAY63-2521)Drug
1 mg single oral dose
Riociguat (BAY63-2521)Drug
2 mg single oral dose
PlaceboDrug
single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Riociguat (BAY63-2521) |
| Arm 2 | Experimental | Not described Receives: Drug: Riociguat (BAY63-2521) |
| Arm 3 | Experimental | Not described Receives: Drug: Riociguat (BAY63-2521) |
| Arm 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary artery mean pressure at rest
Measured: Peak change from baseline within 6 hours after a single dose of study drug
Secondary outcomes (2)
Adverse event collection
Measured: until 30 days after study drug treatment
Plasma concentrations to obtain pharmacokinetic profile of Riociguat
Measured: Within 24 hours after study drug treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Recruitment was only stopped after the statistical power of the study was reached and the study objectives could be met despite the premature discontinuation.
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 Hypertension, PulmonaryStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 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
- NCT01172756
- Sponsor's protocol ID
- 14554
- Other IDs
- 2010-018436-41
- Acronym
- DILATE
- Status last verified
- Nov 2014
- First submitted
- 19 Jul 2010
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bonderman D, Pretsch I, Steringer-Mascherbauer R, Jansa P, Rosenkranz S, Tufaro C, Bojic A, Lam CSP, Frey R, Ochan Kilama M, Unger S, Roessig L, Lang IM. Acute hemodynamic effects of riociguat in patients with pulmonary hypertension associated with diastolic heart failure (DILATE-1): a randomized, double-blind, placebo-controlled, single-dose study. Chest. 2014 Nov;146(5):1274-1285. doi: 10.1378/chest.14-0106.
PubMed 24991733
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Hemodynamic Effects of Riociguat (BAY63-2521) in Patients With Pulmonary Hypertension Associated With Diastolic Heart Failure: A Randomized, Double-blind, Placebo-controlled, Single-dose Study in Three Ascending Dose Cohorts
- ClinicalTrials.gov ID
- NCT01172756
- Acronym / sponsor ID
- DILATE / 14554
- Keywords
- Pulmonary Hypertension, Left ventricular dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was only stopped after the statistical power of the study was reached and the study objectives could be met despite the premature discontinuation.
- Enrolment
- 39 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 30 Jul 2010 (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 aim of this study is to assess whether single oral doses of Riociguat safely improve the cardiovascular function in patients with pulmonary hypertension associated with left ventricular diastolic dysfunction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Riociguat (BAY63-2521) |
| Arm 2 | Experimental | Drug: Riociguat (BAY63-2521) |
| Arm 3 | Experimental | Drug: Riociguat (BAY63-2521) |
| Arm 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female patients with symptomatic pulmonary hypertension due to left ventricular diastolic dysfunction
Key exclusion criteria (1 listed)
- Types of pulmonary hypertension other than group 2.2 of Dana Point Classification
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 (BAY63-2521)0.5 mg single oral dose | Drug | Arm 1 |
| Riociguat (BAY63-2521)1 mg single oral dose | Drug | Arm 2 |
| Riociguat (BAY63-2521)2 mg single oral dose | Drug | Arm 3 |
| Placebosingle oral dose | Drug | Arm 4 |
Primary outcome
Pulmonary artery mean pressure at rest
Time frame: Peak change from baseline within 6 hours after a single dose of study drug
2 secondary outcomes
Adverse event collection
Time frame: until 30 days after study drug treatment
Plasma concentrations to obtain pharmacokinetic profile of Riociguat
Time frame: Within 24 hours after study drug treatment
Results and safety
The study was stopped early (reason given: Recruitment was only stopped after the statistical power of the study was reached and the study objectives could be met despite the premature discontinuation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
- Derived from this study: PubMed 24991733Bonderman D, Pretsch I, Steringer-Mascherbauer R, Jansa P, Rosenkranz S, Tufaro C, Bojic A, Lam CSP, Frey R, Ochan Kilama M, Unger S, Roessig L, Lang IM. Acute hemodynamic effects of riociguat in patients with pulmonary hypertension associated with diastolic heart failure (DILATE-1): a randomized, double-blind, placebo-controlled, single-dose study. Chest. 2014 Nov;146(5):1274-1285. doi: 10.1378/chest.14-0106.
- Click here and search for information of Bayer products for EuropeLink provided by the sponsor.
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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
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Riociguat (BAY63-2521) in people with Hypertension, Pulmonary and Ventricular Dysfunction, Left, run by Bayer at 7 sites in 3 countries.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Austria, Czechia, 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 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 was stopped early (reason given: Recruitment was only stopped after the statistical power of the study was reached and the study objectives could be met despite the premature discontinuation.). Results are not available in the source record.
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?
Pulmonary artery mean pressure at rest (time frame: Peak change from baseline within 6 hours after a single dose of study drug). 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 NCT01172756, 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 4 Nov 2014.