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| ID | Type | Description | Link |
|---|---|---|---|
| 5T32HD069038 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Indiana Clinical and Translational Sciences Institute | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This is a single center, open-label, prospective, investigation to quantify the effects liver congestion and fibrosis has on hepatic drug metabolism and transport in children, adolescents, and young adults with Fontan circulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assessment Arm | Experimental | Assessment group will receive a single dose of oral sildenafil and oral pravastatin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg) | Drug | A single oral dose of sildenafil will be administered to all study subjects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sildenafil concentration as measured by area under the curve (AUC) | Area under the time-exposure curve (AUC 0-n) for sildenafil as determinants of the dose-exposure relationship. | 2 years |
| Pravastatin concentration as measured by area under the curve (AUC) | Area under the time-exposure curve (AUC 0-n) for pravastatin as determinants of the dose-exposure relationship. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonthan Wagner, DO | Contact | 816-731-7240 | jbwagner@cmh.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Wagner, DO | Children's Mercy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospital | Recruiting | Kansas City | Missouri | 64108 | United States |
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This is a single center, open-label, prospective, investigation to quantify the effects of liver congestion and fibrosis has on hepatic statin transport (SA1) and response (SA2) in children, adolescents, and young adults with Fontan circulation.
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| Pravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years) | Drug | A single oral dose of pravastatin will be administered to all study subjects. |
|
| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| D013607 | Tablets |
| D017035 | Pravastatin |
| D017127 | Glycation End Products, Advanced |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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