Hypertension, PulmonaryPhase 1NCT00680654
Interaction Study in Patients With Pulmonary Hypertension and Stable Treatment of Sildenafil 20 mg TID
A Phase 1 study testing Riociguat (Adempas, BAY63-2521) in people with Hypertension, Pulmonary, run by Bayer at 5 sites in Germany.
Trial summary
This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic effect of BAY63-2521 in patients with pulmonary hypertension and stable treatment of sildenafil 20 mg. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- Riociguat (Adempas, BAY63-2521)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 5 sitesGermany
- Study dates
- Oct 2008to Nov 2009
- Phase
- Phase 1
- 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
- Patients with pulmonary hypertension stable for the last 6 weeks
- Treated with Sildenafil 3 × 20 mg
- Undergoing routine invasive diagnostics.
Who cannot join
- Pre-existing lung disease other than pulmonary arterial hypertension,
- Acute or severe chronic left heart failure,
- Severe coronary artery disease,
- Uncontrolled arterial hypertension;
- Congenital or acquired valvular or myocardial disease except acquired tricuspid valve insufficiency due to pulmonary hypertension,
- Systolic blood pressure < 100 mmHg, heart rate < 55 bpm or >105 bpm, PaO2/FiO2 < 50 mmHg,
Show all 10Show fewer
- PaCO2 > 55 mmHg,
- Severe hepatic insufficiency,
- Severe renal insufficiency,
- Administration of strong CYP3A4 inhibitors or inductors
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Study site
Dresden, Saxony, 01307
Study site
Giessen, Hesse, 35392
Study site
Greifswald, Mecklenburg-Vorpommern, 17475
Study site
Heidelberg, Baden-Wurttemberg, 69126
Study site
Löwenstein, Baden-Wurttemberg, 74245
About this study
Official title: Interaction Study to Investigate Safety, Tolerability, Pharmacokinetics and the Impact on Pulmonary and Systemic Hemodynamics of Single Doses of 0.5 and 1 mg of BAY 63-2521 in Patients With PAH and Stable Treatment of Sildenafil 20 mg TID in a Non-randomized, Non-blinded Design
This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic effect of BAY63-2521 in patients with pulmonary hypertension and stable treatment of sildenafil 20 mg.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Riociguat (Adempas, BAY63-2521)
- Keywords
- Pulmonary hypertension
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riociguat (Adempas, BAY63-2521)Drug
The investigational drug will be given twice per subject, as single dose administration of BAY 63-2521 (0.5 mg and 1.0 mg) during the hemodynamic investigation.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Riociguat (Adempas, BAY63-2521) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of a single dose of BAY63-2521 on pharmacodynamic parameters of the pulmonary system, on safety, tolerability and pharmacokinetics.
Measured: At baseline, throughout study days 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startOct 2008
- Primary completionAug 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 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
- NCT00680654
- Sponsor's protocol ID
- 11917
- Other IDs
- 2008-000914-65, 2008
- Status last verified
- Dec 2015
- First submitted
- 16 May 2008
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction Study to Investigate Safety, Tolerability, Pharmacokinetics and the Impact on Pulmonary and Systemic Hemodynamics of Single Doses of 0.5 and 1 mg of BAY 63-2521 in Patients With PAH and Stable Treatment of Sildenafil 20 mg TID in a Non-randomized, Non-blinded Design
- ClinicalTrials.gov ID
- NCT00680654
- Acronym / sponsor ID
- 11917
- Conditions
- Hypertension, Pulmonary
- Keywords
- Pulmonary hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 20 May 2008 (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.
This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic effect of BAY63-2521 in patients with pulmonary hypertension and stable treatment of sildenafil 20 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Riociguat (Adempas, BAY63-2521) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with pulmonary hypertension stable for the last 6 weeks
- Treated with Sildenafil 3 × 20 mg
- Undergoing routine invasive diagnostics.
Key exclusion criteria (10 listed)
- Pre-existing lung disease other than pulmonary arterial hypertension,
- Acute or severe chronic left heart failure,
- Severe coronary artery disease,
- Uncontrolled arterial hypertension;
- Congenital or acquired valvular or myocardial disease except acquired tricuspid valve insufficiency due to pulmonary hypertension,
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)The investigational drug will be given twice per subject, as single dose administration of BAY 63-2521 (0.5 mg and 1.0 mg) during the hemodynamic investigation. | Drug | Arm 1 |
Primary outcome
Impact of a single dose of BAY63-2521 on pharmacodynamic parameters of the pulmonary system, on safety, tolerability and pharmacokinetics.
Time frame: At baseline, throughout study days 1 and 2
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 Dec 2015.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
Related trials for Hypertension, Pulmonary
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Riociguat (Adempas, BAY63-2521) in people with Hypertension, Pulmonary, run by Bayer at 5 sites 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 3 inclusion and 10 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 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Impact of a single dose of BAY63-2521 on pharmacodynamic parameters of the pulmonary system, on safety, tolerability and pharmacokinetics. (time frame: At baseline, throughout study days 1 and 2). 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 Dec 2015.