NCT00686803

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2 hypertension

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_2 hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
5 years until next milestone

Results Posted

Study results publicly available

June 21, 2013

Completed
Last Updated

July 19, 2013

Status Verified

July 1, 2013

Enrollment Period

3 months

First QC Date

May 27, 2008

Results QC Date

August 24, 2011

Last Update Submit

July 8, 2013

Conditions

Hypertension

Keywords

hypertensioncontrolled hypertensionhypertensives

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics of Subcutaneous (SC) PL-3994 Relative to Placebo in Subjects With Controlled Hypertension.

    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.

    24 hours

  • Pharmacodynamics as Measured by cGMP Levels.

    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.

    24 hours

Study Arms (6)

PL3994 Dose A

EXPERIMENTAL

PL3994 Dose A

Drug: PL3994

PL3994 Dose B

EXPERIMENTAL

PL3994 Dose B

Drug: PL3994

PL3994 Dose C

EXPERIMENTAL

PL3994 Dose C

Drug: PL3994

PL3994 Dose D

EXPERIMENTAL

PL3994 Dose D

Drug: PL3994

PL3994 Dose E

EXPERIMENTAL

PL3994 Dose E

Drug: PL3994

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

PL3994DRUG

Study drug

PL3994 Dose APL3994 Dose BPL3994 Dose CPL3994 Dose DPL3994 Dose E
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

PL-3994

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Robert Jordan, Executive Director of Clinical Operations
Organization
Palatin Technologies, Inc.
rjordan@palatin.com
609.495.2200

Study Officials

  • Steven Fischkoff, MD

    Palatin Technologies, Inc

    STUDY DIRECTOR

  • Robert Jordan

    Palatin Technologies, Inc

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2008

First Posted

May 30, 2008

Study Start

April 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

July 19, 2013

Results First Posted

June 21, 2013

Record last verified: 2013-07