Not provided
Not provided
Not provided
Not provided
Not provided
For administrative reasons. Enrollment was sufficient to have statistical power without compromising the integrity of the study data
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novartis | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to determine the pharmacokinetics and safety of elinogrel and its metabolite in patients with mild, moderate, and severe renal impairment compared to healthy volunteers.
Multiple-dose, open-label parallel-group design in patients with mild, moderate or severe renal impairment and age (±7 years), sex and weight (±15% BMI) matched healthy subjects.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-Patients with mild renal impairment | Experimental |
| |
| B-Healthy subjects matched to Group A | Experimental |
| |
| C-Patients with moderate renal impairment | Experimental |
| |
| D-Healthy subjects matched to Group C | Experimental |
| |
| E-Patients with severe renal impairment | Experimental |
| |
| F-Healthy subjects matched to Group E | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elinogrel | Drug | 100 mg elinogrel b.i.d. with aspirin q.d. for 7 days and aspirin alone for 4 days (Dose of aspirin is 81 mg in the US and 100 mg in Germany) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of elinogrel and its metabolite | The PK parameters calculated for both elinogrel and PRT060301 were:
| 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessments will include vital signs, electrocardiograms and adverse events | Safety assessments consisted of collecting all adverse events (AEs), serious adverse events (SAEs), with their severity and relationship to study drug, and pregnancies, regular monitoring of hematology, blood chemistry and urinalysis performed at study center. Safety assessments also included periodic ECG evaluations, assessments of vital signs, physical condition, and body weight. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Matthew W McClure, MD | Portola Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DaVita Clinical Research | Minneapolis | Minnesota | 55404 | United States | ||
| NOCR-Knoxville |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| C549473 | elinogrel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 9 days |
| Measures of platelet function | Platelet aggregation using VerifyNOW P2Y12 assay and thrombi formation using Portola's proprietary PCA (Perfusion Chamber Assay). | 7 days |
| Knoxville |
| Tennessee |
| 37920 |
| United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |