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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005569-70 | EudraCT Number |
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Investigation of the effect of Riociguat, administered as 2.5 mg IR-tablets TID over 14 days, on bone metabolism.
Clinical pharmacology
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Riociguat | Active Comparator | Subjects received multiple doses of riociguat (thrice a day) with concomitant administration of ranitidine (once daily) for 14 days |
|
| Placebo | Placebo Comparator | Subjects received placebo (thrice a day) with concomitant administration of ranitidine (once daily) for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riociguat (Adempas, BAY63-2521) immediate release tablet of 2.5 mg | Drug | Riociguat administered in a dose of 2.5 mg (single tablet), thrice daily, over 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary excretion (over 24 hours) of C-terminal cross-linking telopeptides of type I collagen (CTX) | Marker of bone resorption | From Day -01 to 16 |
| AUC(0-7) | 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) | Pre-dose and up to 7 hours post-dose on Day 0 |
| AUC(0-7)ss | AUC(0-7) at steady state | Pre-dose and up to 7 hours post-dose on Day 13 |
| Cmax | Maximum drug concentration in plasma after single dose administration for riociguat and its metabolite M-1 (BAY60-4552) | Pre-dose and up to 7 hours post-dose on Day 0 |
| Cmax,ss | Maximum drug concentration in plasma at steady state during a dosage interval for riociguat and its metabolite M-1 (BAY60-4552) | Pre-dose and up to 7 hours post-dose on Day 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Approximately 12 weeks | |
| Ctrough | Drug concentration in plasma at expected time of minimum (trough) concentration for riociguat and its metabolite M-1 (BAY60-4552) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cologne | North Rhine-Westphalia | 51147 | Germany |
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe. | View source |
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| ID | Term |
|---|---|
| C542595 | riociguat |
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| Placebo | Drug | Placebo administered as a single tablet, thrice daily, over 14 days. |
|
| On Days 03 and 08 |
| AUC(0-7)norm | AUC(0-7) divided by dose per kg body weight for riociguat and its metabolite M-1 (BAY60-4552) | Pre-dose and up to 7 hours post-dose on Day 0 |
| AUC(0-7)ss,norm | AUC(0-7)ss divided by dose per kg body weight for riociguat and its metabolite M-1 (BAY60-4552) | Pre-dose and up to 7 hours post-dose on Day 13 |
| Cmax,norm | 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) | Pre-dose and up to 7 hours post-dose on Day 0 |
| Cmax,ss,norm | 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) | Pre-dose and up to 7 hours post-dose on Day 13 |
| tmax | Time to reach maximum drug concentration in plasma after single (first) dose for riociguat and its metabolite M-1 (BAY60-4552) | Pre-dose and up to 7 hours post-dose on Day 0 |
| tmax,ss | tmax at steady state for riociguat and its metabolite M-1 (BAY60-4552) | Pre-dose and up to 7 hours post-dose on Day 13 |
| Aeur(0-7) | Amount of drug excreted via urine from zero to 7 hours after administration for riociguat and its metabolite M-1 (BAY60-4552) | Pre-dose and up to 7 hours post-dose |
| %Aeur(0-7) | Aeur(0-7) expressed as percent of dose administered for riociguat and its metabolite M-1 (BAY60-4552) | Pre-dose and up to 7 hours post-dose |
| Urinary excretion (over 24 hours) of N-terminal cross-linking telopeptides of type I collagen (NTX) | Marker of bone resorption | From -01 to 16 Days |
| Serum CTX | Marker of bone resorption | From -01 to 16 Days |
| Serum N-terminal propeptide of type I collagen (PINP) | Marker of bone formation | From -01 to 16 Days |
| Serum bone-specific alkaline phosphatase (bAP) | Marker of bone formation | From -01 to 16 Days |
| Serum albumin, protein | Determination of albumin, protein in serum | From -01 to 16 Days |
| Cyclic guanosine monophosphate (cGMP) | Determination of cGMP in plasma and urinary excretion (over 24 hours) | From -01 to 16 Days |
| Calcium, sodium, potassium | Determination of calcium, sodium, potassium in serum and urinary excretion (over 24 hours) | From -01 to 16 Days |
| Urine volume | Volume of urine excreted (over 24 hours) | From -01 to 16 Days |
| Renin | Determination of plasma renin level | From -01 to 16 Days |
| Creatinine clearance | For estimation of glomerular filtration rate | From -01 to 16 Days |
| Serum osteocalcin | Determination of osteocalcin in serum | From -01 to 16 Days |
| Creatinine | Determination of creatinine in serum and urinary excretion (over 24 hours) | From -01 to 16 Days |
| Phosphate | Determination of phosphate in serum only | From -01 to 16 Days |
| Parathyroid hormone (PTH) | Determination of PTH in serum only | From -01 to 16 Days |