Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
17 participants
INTERVENTIONAL
2009-03-31
2010-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone
NCT00445575
Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance -
NCT02106455
Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis
NCT00619957
Changes in Bone Turnover With Exposure to a GLP-1 Receptor Agonist
NCT01381926
Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women
NCT00353080
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Riociguat
Subjects received multiple doses of riociguat (thrice a day) with concomitant administration of ranitidine (once daily) for 14 days
Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mg
Riociguat administered in a dose of 2.5 mg (single tablet), thrice daily, over 14 days.
Placebo
Subjects received placebo (thrice a day) with concomitant administration of ranitidine (once daily) for 14 days
Placebo
Placebo administered as a single tablet, thrice daily, over 14 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mg
Riociguat administered in a dose of 2.5 mg (single tablet), thrice daily, over 14 days.
Placebo
Placebo administered as a single tablet, thrice daily, over 14 days.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 18 to 45 years of age
* BMI between 18 and 28 kg/m2
* Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period
Exclusion Criteria
* Resting heart rate in the awake subject below 45 BPM or above 90 BPM
* Systolic blood pressure below 100 mmHg or above 145 mmHg
* Diastolic blood pressure above 95 mmHg
* Relevant pathological changes in the ECG such as a second or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QT / QTc-interval over 450 msec for males
* History of genetic muscle or bone disease of any kind
* Completely sedentary or extremely fit subjects
* Fractures in the preceding 12 months
* Psychiatric diseases
* History of peptic ulcers or relevant gastro-esophageal reflux disease
* Subjects with hypersensitivity to the investigational drug riociguat or ranitidine, or to inactive constituents
* Regular daily consumption of more than half a liter of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form, more than 1 L of xanthine-containing beverages, recent smoking history
* Use of medication within the 2 weeks preceding the study which could have interfered with the investigational drug riociguat or ranitidine
* Subjects with a medical disorder, condition or history of such that would have impaired the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
18 Years
45 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cologne, North Rhine-Westphalia, Germany
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2008-005569-70
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
13790
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.