NCT00686803

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

A Single-Center, Single-Dose, Placebo-Controlled, Randomized, Double-Blind, Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered PL-3994 in Subjects With Controlled Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Palatin Technologies, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	PL3994	Study drug
DRUG	Placebo	Placebo

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2008-05-30
• Last updated: 2013-07-19
• Results posted: 2013-06-21