Trial · NCT00730912
Post Approval Pharmacokinetic Study of Loratadine in Japanese Pediatric and Adult Patients (Study P05539)
NCT00730912, Phase 4, Completed, Merck Sharp & Dohme LLC; results first posted 2010-07-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Post Approval Pharmacokinetic Study of Loratadine in Japanese Pediatric and Adult Patients (Study P05539). Trials, record NCT00730912. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00730912
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Post Approval Pharmacokinetic Study of Loratadine in Japanese Pediatric and Adult Patients (Study P05539)
- NCT number
- NCT00730912
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 261 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Perennial Allergic Rhinitis
- Interventions
- loratadine, loratadine, loratadine
- First posted
- 2008-08-08
- Last updated
- 2017-04-13
- Results first posted
- 2010-07-05
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117) | After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed | SCH 29851: Two-compartment model used as basic pharmacokinetic (PK) model. Individual Cmax estimated with basic PPK parameters (apparent total body clearance (CL/F), apparent distribution volumes of central compartment (Vc/F) and peripheral compartment (Vp/F), apparent inter-compartmental clearance (Q/F), absorption rate constant (Ka), lag time, inter- and intra-individual variation) by Bayesian method. SCH 34117/SCH 45581: One-compartment model used as basic PK model. Individual Cmax was estimated with PPK parameters (above) on final model by Bayesian method. |
| Primary | Mean Area Under the Plasma Concentration Time Curve (AUC) of SCH 29851 (Unchanged Drug), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117) | After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed | SCH 29851: Two-compartment model used as basic pharmacokinetic (PK) model. Individual AUC estimated with basic PPK parameters (apparent total body clearance (CL/F), apparent distribution volumes of central compartment (Vc/F) and peripheral compartment (Vp/F), apparent inter-compartmental clearance (Q/F), absorption rate constant (Ka), lag time, inter- and intra-individual variation) by Bayesian method. SCH 34117/SCH 45581: One-compartment model used as basic PK model. Individual AUC was estimated with PPK parameters (above) on final model by Bayesian method. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117) | After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed | Number of participants for SCH 29851 were 53, 104, and 104. Number of participants for SCH 34117 were 53, 102, and 104. Number of participants for SCH 44581 were 53, 99, and 104. | ng/mL | MEAN |
| PRIMARY | Mean Area Under the Plasma Concentration Time Curve (AUC) of SCH 29851 (Unchanged Drug), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117) | After 2 and 4 weeks of treatment, and after 1 and 3 weeks of treatment if participant agreed | Number of participants for SCH 29851 were 53, 104, and 104. Number of participants for SCH 34117 were 53, 102, and 104. Number of participants for SCH 44581 were 53, 99, and 104. | ng•hr/mL | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117) | Pediatrics 3 to 6 Years | SCH 29851 | 3.04 | Standard Deviation 1.78 | ng/mL |
| Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117) | Pediatrics 7 to 15 Years | SCH 29851 | 5.54 | Standard Deviation 3.15 | ng/mL |
| Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117) | Adults 16 to 64 Years | SCH 29851 | 6.48 | Standard Deviation 3.28 | ng/mL |
| Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117) | Pediatrics 3 to 6 Years | SCH 34117 | 4.16 | Standard Deviation 1.26 | ng/mL |
| Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117) | Pediatrics 7 to 15 Years | SCH 34117 | 4.30 | Standard Deviation 1.63 | ng/mL |
| Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117) | Adults 16 to 64 Years | SCH 34117 | 4.61 | Standard Deviation 1.41 | ng/mL |
| Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117) | Pediatrics 3 to 6 Years | SCH 45581 | 2.58 | Standard Deviation 0.76 | ng/mL |
| Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117) | Pediatrics 7 to 15 Years | SCH 45581 | 2.56 | Standard Deviation 0.86 | ng/mL |
| Mean Maximum Plasma Concentration (Cmax) of SCH 29851 (Unchanged Drug; Loratadine), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117) | Adults 16 to 64 Years | SCH 45581 | 2.35 | Standard Deviation 0.54 | ng/mL |
| Mean Area Under the Plasma Concentration Time Curve (AUC) of SCH 29851 (Unchanged Drug), SCH 34117 (Active Metabolite), and SCH 45581 (3OH-SCH 34117) | Pediatrics 3 to 6 Years | SCH 29851 | 16.77 | Standard Deviation 14.87 | ng•hr/mL |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pediatrics 3 to 6 Years | 53 | |
| Overall Study | STARTED | Pediatrics 7 to 15 Years | 104 | |
| Overall Study | STARTED | Adults 16 to 64 Years | 104 | |
| Overall Study | COMPLETED | Pediatrics 3 to 6 Years | 53 | |
| Overall Study | COMPLETED | Pediatrics 7 to 15 Years | 104 | |
| Overall Study | COMPLETED | Adults 16 to 64 Years | 103 | |
| Overall Study | NOT COMPLETED | Pediatrics 3 to 6 Years | 0 | |
| Overall Study | NOT COMPLETED | Pediatrics 7 to 15 Years | 0 | |
| Overall Study | NOT COMPLETED | Adults 16 to 64 Years | 1 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Acute Tonsillitis | Infections and infestations | Pediatrics 3 to 6 Years | 3 | 53 | 3 |
| other | Acute Tonsillitis | Infections and infestations | Pediatrics 7 to 15 Years | 0 | 104 | 0 |
| other | Acute Tonsillitis | Infections and infestations | Adults 16 to 64 Years | 0 | 104 | 0 |
| other | Bronchitis | Infections and infestations | Pediatrics 3 to 6 Years | 3 | 53 | 4 |
| other | Bronchitis | Infections and infestations | Pediatrics 7 to 15 Years | 1 | 104 | 1 |
| other | Bronchitis | Infections and infestations | Adults 16 to 64 Years | 0 | 104 | 0 |
| other | Nasopharyngitis | Infections and infestations | Pediatrics 3 to 6 Years | 5 | 53 | 6 |
| other | Nasopharyngitis | Infections and infestations | Pediatrics 7 to 15 Years | 1 | 104 | 1 |
| other | Nasopharyngitis | Infections and infestations | Adults 16 to 64 Years | 9 | 104 | 11 |
| other | Pharyngitis | Infections and infestations | Pediatrics 3 to 6 Years | 9 | 53 | 10 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pediatrics 3 to 6 Years | ||
| Total, all-cause mortality | Pediatrics 7 to 15 Years | ||
| Total, all-cause mortality | Adults 16 to 64 Years | ||
| Total, other adverse events | Pediatrics 3 to 6 Years | 23 | 53 |
| Total, other adverse events | Pediatrics 7 to 15 Years | 17 | 104 |
| Total, other adverse events | Adults 16 to 64 Years | 17 | 104 |
| Total, serious adverse events | Pediatrics 3 to 6 Years | 0 | 53 |
| Total, serious adverse events | Pediatrics 7 to 15 Years | 0 | 104 |
| Total, serious adverse events | Adults 16 to 64 Years | 0 | 104 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00730912
GET https://conductscience.org/api/trials/v1/NCT00730912/events?page=2