Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-07 @ 3:11 PM
Study NCT ID:
NCT00855660
Status:
COMPLETED
Last Update Posted:
2016-01-11
First Post:
2009-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Riociguat on Bone Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C542595', 'term': 'riociguat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-07', 'studyFirstSubmitDate': '2009-03-03', 'studyFirstSubmitQcDate': '2009-03-03', 'lastUpdatePostDateStruct': {'date': '2016-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary excretion (over 24 hours) of C-terminal cross-linking telopeptides of type I collagen (CTX)', 'timeFrame': 'From Day -01 to 16', 'description': 'Marker of bone resorption'}, {'measure': 'AUC(0-7)', 'timeFrame': 'Pre-dose and up to 7 hours post-dose on Day 0', 'description': 'Area under the plasma concentration vs time curve (AUC) from zero to 7 hours after single (first) dose for riociguat and its metabolite M-1 (BAY60-4552)'}, {'measure': 'AUC(0-7)ss', 'timeFrame': 'Pre-dose and up to 7 hours post-dose on Day 13', 'description': 'AUC(0-7) at steady state'}, {'measure': 'Cmax', 'timeFrame': 'Pre-dose and up to 7 hours post-dose on Day 0', 'description': 'Maximum drug concentration in plasma after single dose administration for riociguat and its metabolite M-1 (BAY60-4552)'}, {'measure': 'Cmax,ss', 'timeFrame': 'Pre-dose and up to 7 hours post-dose on Day 13', 'description': 'Maximum drug concentration in plasma at steady state during a dosage interval for riociguat and its metabolite M-1 (BAY60-4552)'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': 'Approximately 12 weeks'}, {'measure': 'Ctrough', 'timeFrame': 'On Days 03 and 08', 'description': 'Drug concentration in plasma at expected time of minimum (trough) concentration for riociguat and its metabolite M-1 (BAY60-4552)'}, {'measure': 'AUC(0-7)norm', 'timeFrame': 'Pre-dose and up to 7 hours post-dose on Day 0', 'description': 'AUC(0-7) divided by dose per kg body weight for riociguat and its metabolite M-1 (BAY60-4552)'}, {'measure': 'AUC(0-7)ss,norm', 'timeFrame': 'Pre-dose and up to 7 hours post-dose on Day 13', 'description': 'AUC(0-7)ss divided by dose per kg body weight for riociguat and its metabolite M-1 (BAY60-4552)'}, {'measure': 'Cmax,norm', 'timeFrame': 'Pre-dose and up to 7 hours post-dose on Day 0', 'description': 'Maximum drug concentration in plasma after (first) single dose administration divided by dose (mg) per kg body weight for riociguat and its metabolite M-1 (BAY60-4552)'}, {'measure': 'Cmax,ss,norm', 'timeFrame': 'Pre-dose and up to 7 hours post-dose on Day 13', 'description': 'Maximum drug concentration in plasma at steady state during a dosage interval divided by dose (mg) per kg body weight for riociguat and its metabolite M-1 (BAY60-4552)'}, {'measure': 'tmax', 'timeFrame': 'Pre-dose and up to 7 hours post-dose on Day 0', 'description': 'Time to reach maximum drug concentration in plasma after single (first) dose for riociguat and its metabolite M-1 (BAY60-4552)'}, {'measure': 'tmax,ss', 'timeFrame': 'Pre-dose and up to 7 hours post-dose on Day 13', 'description': 'tmax at steady state for riociguat and its metabolite M-1 (BAY60-4552)'}, {'measure': 'Aeur(0-7)', 'timeFrame': 'Pre-dose and up to 7 hours post-dose', 'description': 'Amount of drug excreted via urine from zero to 7 hours after administration for riociguat and its metabolite M-1 (BAY60-4552)'}, {'measure': '%Aeur(0-7)', 'timeFrame': 'Pre-dose and up to 7 hours post-dose', 'description': 'Aeur(0-7) expressed as percent of dose administered for riociguat and its metabolite M-1 (BAY60-4552)'}, {'measure': 'Urinary excretion (over 24 hours) of N-terminal cross-linking telopeptides of type I collagen (NTX)', 'timeFrame': 'From -01 to 16 Days', 'description': 'Marker of bone resorption'}, {'measure': 'Serum CTX', 'timeFrame': 'From -01 to 16 Days', 'description': 'Marker of bone resorption'}, {'measure': 'Serum N-terminal propeptide of type I collagen (PINP)', 'timeFrame': 'From -01 to 16 Days', 'description': 'Marker of bone formation'}, {'measure': 'Serum bone-specific alkaline phosphatase (bAP)', 'timeFrame': 'From -01 to 16 Days', 'description': 'Marker of bone formation'}, {'measure': 'Serum albumin, protein', 'timeFrame': 'From -01 to 16 Days', 'description': 'Determination of albumin, protein in serum'}, {'measure': 'Cyclic guanosine monophosphate (cGMP)', 'timeFrame': 'From -01 to 16 Days', 'description': 'Determination of cGMP in plasma and urinary excretion (over 24 hours)'}, {'measure': 'Calcium, sodium, potassium', 'timeFrame': 'From -01 to 16 Days', 'description': 'Determination of calcium, sodium, potassium in serum and urinary excretion (over 24 hours)'}, {'measure': 'Urine volume', 'timeFrame': 'From -01 to 16 Days', 'description': 'Volume of urine excreted (over 24 hours)'}, {'measure': 'Renin', 'timeFrame': 'From -01 to 16 Days', 'description': 'Determination of plasma renin level'}, {'measure': 'Creatinine clearance', 'timeFrame': 'From -01 to 16 Days', 'description': 'For estimation of glomerular filtration rate'}, {'measure': 'Serum osteocalcin', 'timeFrame': 'From -01 to 16 Days', 'description': 'Determination of osteocalcin in serum'}, {'measure': 'Creatinine', 'timeFrame': 'From -01 to 16 Days', 'description': 'Determination of creatinine in serum and urinary excretion (over 24 hours)'}, {'measure': 'Phosphate', 'timeFrame': 'From -01 to 16 Days', 'description': 'Determination of phosphate in serum only'}, {'measure': 'Parathyroid hormone (PTH)', 'timeFrame': 'From -01 to 16 Days', 'description': 'Determination of PTH in serum only'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bone Metabolism'], 'conditions': ['Pharmacology, Clinical']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe.'}]}, 'descriptionModule': {'briefSummary': 'Investigation of the effect of Riociguat, administered as 2.5 mg IR-tablets TID over 14 days, on bone metabolism.', 'detailedDescription': 'Clinical pharmacology'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male white subjects\n* 18 to 45 years of age\n* BMI between 18 and 28 kg/m2\n* Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period\n\nExclusion Criteria:\n\n* Relevant deviation from the normal range in the clinical examination; in clinical chemistry, hematology, or urinalysis\n* Resting heart rate in the awake subject below 45 BPM or above 90 BPM\n* Systolic blood pressure below 100 mmHg or above 145 mmHg\n* Diastolic blood pressure above 95 mmHg\n* 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\n* History of genetic muscle or bone disease of any kind\n* Completely sedentary or extremely fit subjects\n* Fractures in the preceding 12 months\n* Psychiatric diseases\n* History of peptic ulcers or relevant gastro-esophageal reflux disease\n* Subjects with hypersensitivity to the investigational drug riociguat or ranitidine, or to inactive constituents\n* 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\n* Use of medication within the 2 weeks preceding the study which could have interfered with the investigational drug riociguat or ranitidine\n* 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"}, 'identificationModule': {'nctId': 'NCT00855660', 'briefTitle': 'Effect of Riociguat on Bone Metabolism', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Investigation of the Effect of Riociguat, Administered as 2.5 mg IR-tablets TID Over 14 Days, on Bone Metabolism in a Randomized, Placebo-controlled, Double-blind, 2-fold Cross-over Design in Healthy Male Subjects', 'orgStudyIdInfo': {'id': '13790'}, 'secondaryIdInfos': [{'id': '2008-005569-70', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Riociguat', 'description': 'Subjects received multiple doses of riociguat (thrice a day) with concomitant administration of ranitidine (once daily) for 14 days', 'interventionNames': ['Drug: Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects received placebo (thrice a day) with concomitant administration of ranitidine (once daily) for 14 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mg', 'type': 'DRUG', 'description': 'Riociguat administered in a dose of 2.5 mg (single tablet), thrice daily, over 14 days.', 'armGroupLabels': ['Riociguat']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo administered as a single tablet, thrice daily, over 14 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51147', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}