Safety Study of Subcutaneously Administered PL-3994 in Subjects With Controlled Hypertension

Phase 2

Completed

• Conditions: Hypertension
• Interventions: Drug: PL3994; Drug: Placebo

• Registration Number: NCT00686803
• Lead Sponsor: Palatin Technologies, Inc

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-27
• Study First Submitted QC: 2008-05-29
• Study First Posted: 2008-05-30
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2011-08-24
• Results First Submitted QC: 2013-05-13
• Results First Posted: 2013-06-21
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-08
• Last Update Posted: 2013-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Subjects must have had a diagnosis of essential hypertension for at least 1 year, per subject verbal history
• Subject must be on a stable dose of at least one, but not more than 3 antihypertensive medications for at least 3 months, per subject verbal history.
• Subject must have a systolic blood pressure at screening between 100 and 150 mmHg, and diastolic blood pressure must not exceed 105 mmHg.

Exclusion Criteria

• Subject weight greater than 100 kg or less than 50 kg.
• Any significant medical condition or abnormal safety laboratory results which, in the judgement of the Investigator would place the subject at significant risk.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PL3994 Dose A	PL3994	PL3994 Dose A
PL3994 Dose B	PL3994	PL3994 Dose B
PL3994 Dose E	PL3994	PL3994 Dose E
Placebo	Placebo	Placebo
PL3994 Dose C	PL3994	PL3994 Dose C
PL3994 Dose D	PL3994	PL3994 Dose D

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of Subcutaneous (SC) PL-3994 Relative to Placebo in Subjects With Controlled Hypertension.	24 hours	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.
Pharmacodynamics as Measured by cGMP Levels.	24 hours	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.