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

Palatin Technologies

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: Placebo; Drug: PL3994

Study type: Interventional

Funder types: Industry

Identifiers

NCT00686803

PL3994-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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21 participants in 6 patient groups, including a placebo group

PL3994 Dose A

Experimental group

Description:

PL3994 Dose A

Treatment:

Drug: PL3994

PL3994 Dose B

Experimental group

Description:

PL3994 Dose B

Treatment:

Drug: PL3994

PL3994 Dose C

Experimental group

Description:

PL3994 Dose C

Treatment:

Drug: PL3994

PL3994 Dose D

Experimental group

Description:

PL3994 Dose D

Treatment:

Drug: PL3994

PL3994 Dose E

Experimental group

Description:

PL3994 Dose E

Treatment:

Drug: PL3994

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo