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The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of subcutaneous (SC) PL-3994, relative to placebo in subjects with controlled hypertension. Including in this evaluation is the effect PL3994 has on blood pressure.
Uncontrolled hypertension, including both hypertensive urgency and hypertensive emergency, is commonly seen in emergency rooms and other urgent care settings. Current standards of care include intravenously administered drugs, which can be difficult to titrate and require ongoing monitoring. This study examines the effect of PL-3994 on patients with controlled hypertension who are receiving antihypertensive medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PL3994 Dose A | Experimental | PL3994 Dose A |
|
| PL3994 Dose B | Experimental | PL3994 Dose B |
|
| PL3994 Dose C | Experimental | PL3994 Dose C |
|
| PL3994 Dose D | Experimental | PL3994 Dose D |
|
| PL3994 Dose E | Experimental | PL3994 Dose E |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PL3994 | Drug | Study drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of Subcutaneous (SC) PL-3994 Relative to Placebo in Subjects With Controlled Hypertension. | The pharmacokinetic profile parameters for PL-3994 were calculated using a non compartmental approach. •Maximum concentration (Cmax) The subject numbers below are the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PK parameters were possible. | 24 hours |
| Pharmacodynamics as Measured by cGMP Levels. | Pharmacodynamic parameters were calculated from the baseline-adjusted plasma cGMP level-time data using WinNonlin® 5.0.1. Actual sample times were used in the calculations. Baseline was the pre-dose levels of plasma cGMP at Visit 2 (Day 1): Emax The patient numbers below represent the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PD parameters were possible. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Fischkoff, MD | Palatin Technologies, Inc | Study Director |
| Robert Jordan | Palatin Technologies, Inc | Study Director |
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Some results (i.e.Pharmacodynamic results) may include analyses only for the Evaluable Subjects population.The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PK or PD parameters were possible.
Initiation Date: 28 April 2008 Completion Date: 21 July 2008 Cohort 1: 6 subjects: PL-3994 0.3 µg/kg; 1 subject Placebo Cohort 2: 6 subjects: PL-3994 0.1 µg/kg; 1 subject Placebo Cohort 3: 6 subjects: PL-3994 0.3 µg/kg; 1 subject Placebo; Study stopped after Cohort 3.
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| ID | Title | Description |
|---|---|---|
| FG000 | PL-3994 0.1 µg/kg | PL-3994 0.1 µg/kg |
| FG001 | PL-3994 0.3 µg/kg | PL-3994 0.3 µg/kg |
| FG002 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PL-3994 0.1 µg/kg | PL-3994 0.1 µg/kg |
| BG001 | PL-3994 0.3 µg/kg | PL-3994 0.3 µg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics of Subcutaneous (SC) PL-3994 Relative to Placebo in Subjects With Controlled Hypertension. | The pharmacokinetic profile parameters for PL-3994 were calculated using a non compartmental approach. •Maximum concentration (Cmax) The subject numbers below are the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PK parameters were possible. | Posted | Mean | Standard Deviation | ng/mL | 24 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PL-3994 0.1 µg/kg | PL-3994 0.1 µg/kg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Jordan, Executive Director of Clinical Operations | Palatin Technologies, Inc. | 609.495.2200 | rjordan@palatin.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C583022 | PL-3994 |
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| Placebo | Drug | Placebo |
|
| BG002 |
| Placebo |
Placebo |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Placebo | Placebo |
|
|
| Primary | Pharmacodynamics as Measured by cGMP Levels. | Pharmacodynamic parameters were calculated from the baseline-adjusted plasma cGMP level-time data using WinNonlin® 5.0.1. Actual sample times were used in the calculations. Baseline was the pre-dose levels of plasma cGMP at Visit 2 (Day 1): Emax The patient numbers below represent the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PD parameters were possible. | Posted | Median | Full Range | ng/mL | 24 hours |
|
|
|
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | PL-3994 0.3 µg/kg | PL-3994 0.3 µg/kg | 0 | 12 | 6 | 12 |
| EG002 | Placebo | Placebo | 0 | 3 | 3 | 3 |
| headache | Nervous system disorders |
|
| somnolence | Nervous system disorders |
|
| nausea | Gastrointestinal disorders |
|
| dizziness postural | Nervous system disorders |
|
| fatigue | General disorders |
|
| feeling hot | General disorders |
|
| Oedema peripheral | General disorders |
|
| vessel puncture site pain | General disorders |
|
| vomiting | Gastrointestinal disorders |
|
| muscle spasms | Musculoskeletal and connective tissue disorders |
|
| musculoskelatal stiffness | Musculoskeletal and connective tissue disorders |
|
| platelet count decreased | Investigations |
|
| depersonalization | Psychiatric disorders |
|
| urinary tract inflammation | Renal and urinary disorders |
|
| ecchymosis | Skin and subcutaneous tissue disorders |
|
| hypotension | Vascular disorders |
|
PI was an employed by Palatin, as he was/is an employee of the CRO hired by Palatin to conduct the study. All confidentiality agreed upon between Palatin and the CRO applies.