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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-07-31

Brief Summary

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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.

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Detailed Description

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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

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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PL3994 Dose A

Group Type EXPERIMENTAL

PL3994

Intervention Type DRUG

Study drug

PL3994 Dose B

Group Type EXPERIMENTAL

PL3994

Intervention Type DRUG

Study drug

PL3994 Dose C

Group Type EXPERIMENTAL

PL3994

Intervention Type DRUG

Study drug

PL3994 Dose D

Group Type EXPERIMENTAL

PL3994

Intervention Type DRUG

Study drug

PL3994 Dose E

Group Type EXPERIMENTAL

PL3994

Intervention Type DRUG

Study drug

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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PL3994

Study drug

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No