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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003819-22 | EudraCT Number |
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A business decision was made to not initiate this study
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| Name | Class |
|---|---|
| Janssen Biotech, Inc. | INDUSTRY |
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The purpose of this research study is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to the background antihypertensive therapy in patients with uncontrolled blood pressure and chronic kidney disease (CKD) stage 3 or 4. Participation in the research study will last up to 21 weeks (about 5 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aprocitentan 25 mg | Experimental |
| |
| Placebo | Experimental |
| |
| Aprocitentan 25 mg or Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aprocitentan 25 mg | Drug | Tablet, oral use once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to Week 4 of double-blind treatment in mean trough sitting systolic blood pressure measured by automated office blood pressure measurement. | From baseline to Week 4 after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Week 4 of double-blind treatment in mean trough sitting diastolic blood pressure measured by automated office blood pressure measurement. | From baseline to Week 4 after treatment initiation | |
| Ratio to baseline of urine albumin-to-creatinine ratio (UACR) at Week 4 |
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Inclusion Criteria:
Prior treatment with at least 2 anti-hypertensive medications, at optimal or best tolerated dose, of different pharmacological classes, including a diuretic,
Participants with uncontrolled blood pressure (mean sitting systolic blood pressure of 140 mmHg or greater) and chronic kidney disease stage 3 or 4 (estimated Glomerular Filtration Rate of at least 15 and below 60 mL/min/1.73m2 using the Chronic Kidney Disease-Epidemiology equation),
Women of childbearing potential are eligible only if the following applies:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Idorsia Pharmaceuticals Ltd. | Study Director |
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All participants will get the active drug, aprocitentan 25 mg, for at least 8 weeks. All participants will receive placebo for 2 weeks. During a certain period of the study, participants will receive aprocitentan 25 mg or placebo for 4 weeks.
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| Placebo | Drug | Matching placebo tablet, oral use once daily |
|
Evaluated in the subgroup of participants with a UACR greater than 30 mg/g at baseline.
| From baseline to Week 4 after treatment initiation |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C572762 | aprocitentan |
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