HypertensionPhase 2NCT00686803

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

A Phase 2 study testing PL3994 in people with Hypertension, run by Palatin Technologies, Inc.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hypertension
What is being tested?: PL3994
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 21 participants
Where: No sites listed yet
Study dates: Apr 2008to Jul 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

About this study

Official title: 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

Read the 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
Being tested: PL3994, Placebo
Keywords: hypertension, controlled hypertension, hypertensives
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PL3994Drug
Study drug
PlaceboDrug
Placebo

Study groups in NCT00686803
Study group	Role	What they receive
PL3994 Dose A	Experimental	PL3994 Dose A Receives: Drug: PL3994
PL3994 Dose B	Experimental	PL3994 Dose B Receives: Drug: PL3994
PL3994 Dose C	Experimental	PL3994 Dose C Receives: Drug: PL3994
PL3994 Dose D	Experimental	PL3994 Dose D Receives: Drug: PL3994
PL3994 Dose E	Experimental	PL3994 Dose E Receives: Drug: PL3994
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Jul 2008

First posted30 May 2008 (estimated)
Study startApr 2008
Primary completionJul 2008
Study completionJul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00686803
Sponsor's protocol ID: PL3994-003
Status last verified: Jul 2013
First submitted: 27 May 2008
Last updated: 19 Jul 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00686803
Acronym / sponsor ID: PL3994-003
Conditions: Hypertension
Keywords: hypertension, controlled hypertension, hypertensives
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Palatin Technologies, IncIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 30 May 2008 (estimated)
Results: Posted 21 Jun 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6

Arm	Type	Receives
PL3994 Dose A	Experimental	Drug: PL3994PL3994 Dose A
PL3994 Dose B	Experimental	Drug: PL3994PL3994 Dose B
PL3994 Dose C	Experimental	Drug: PL3994PL3994 Dose C
PL3994 Dose D	Experimental	Drug: PL3994PL3994 Dose D
PL3994 Dose E	Experimental	Drug: PL3994PL3994 Dose E
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PL3994Study drug	Drug	PL3994 Dose A, PL3994 Dose B, PL3994 Dose C, PL3994 Dose D, PL3994 Dose E
PlaceboPlacebo	Drug	Placebo

Primary outcome

Pharmacokinetics of Subcutaneous (SC) PL-3994 Relative to Placebo in Subjects With Controlled Hypertension.
Time frame: 24 hours
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.
Pharmacodynamics as Measured by cGMP Levels.
Time frame: 24 hours
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.

Results and safety

Results posted to the registry on 21 Jun 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PL-3994 0.1 µg/kg	6	6
PL-3994 0.3 µg/kg	12	12
Placebo	3	3

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

Time frame: 24 hours. Mean (Standard Deviation). Unit: ng/mL

Measure	PL-3994 0.1 µg/kg n = 6	PL-3994 0.3 µg/kg n = 12	Placebo n = 3
Value	0 (0)	0.366 (0.0656)	0 (0)

Primary outcome: Pharmacodynamics as Measured by cGMP Levels.

Time frame: 24 hours. Median (Full Range). Unit: ng/mL

Measure	PL-3994 0.1 µg/kg n = 3	PL-3994 0.3 µg/kg n = 8	Placebo n = 1
Value	0.996 (0.38 to 1.03)	1.435 (0.87 to 4.26)	0.676 (0.676 to 0.676)

Adverse events

Other adverse events reported at 4.8% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PL-3994 0.1 µg/kg	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
PL-3994 0.3 µg/kg	0 of 12 (0%)	6 of 12 (50%)	Not reported
Placebo	0 of 3 (0%)	3 of 3 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steven Fischkoff, MD study director

Palatin Technologies, Inc

Robert Jordan study director

Palatin Technologies, Inc

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PL3994 in people with Hypertension, run by Palatin Technologies, Inc.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics of Subcutaneous (SC) PL-3994 Relative to Placebo in Subjects With Controlled Hypertension. (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00686803.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2013.