Overview

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

Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Palatin Technologies
Criteria
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.