Blood PressurePhase 2NCT00739193
A Randomized, Placebo-Controlled, Double-Blind, Double Dummy Trial To Determine The Relative Effect Of Pm101 Versus Placebo And Amiodarone IV On Blood Pressure In Subjects With Stable Congestive Heart Failure
A Phase 2 study testing amiodarone in people with Blood Pressure, run by Prism Pharmaceuticals.
Trial summary
The primary objective of this trial is to compare the relative hemodynamic effect of a novel intravenous formulation of amiodarone (PM101), administered as an immediate IV bolus push, with placebo and with the currentlyl available formulation of Amiodarone IV, administered as a 10-minute IV infusion, on systolic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- amiodarone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women >18 years of age at Screening, with a diagnosis of stable congestive heart failure
- NYHA Functional Classification of Heart Failure Class II, III, or IV
- Documented left ventricular ejection fraction ≤35% within 6 months before Screening, provided that the assessment was not within 4 weeks of a myocardial infarction
- Outpatient or inpatient
- On stable doses of medications to treat congestive heart failure (eg, beta-blockers, angiotensin-converting enzyme inhibitor/angiotensin-receptor antagonist, diuretic) for at least 7 days before dosing with trial drug
- Have a 12-lead electrocardiogram (ECG) at Screening that shows no clinically significant abnormalities of rate, rhythm, or conduction (such as high-grade atrioventricular block, bifascicular or trifascicular block), that would jeopardize the safety or the ability to accurately measure the arterial pressure of the subject, in the opinion of the investigator
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- Able to communicate effectively with the trial personnel
- Able to undergo study related procedures as required by the protocol
- Adequately informed of the nature and risks of the trial and give written informed consent prior to undergoing any trial-related procedures
- Women of childbearing potential must have a negative pregnancy test both at Screening and at check-in to the trial site before receiving trial drug on Day 1 and must be using an effective medically acceptable form of birth control for the duration of the trial (up through the Day 8 follow-up evaluation)
Who cannot join
- Known hypersensitivity or allergy to amiodarone, Captisol, Amiodarone IV, or any of its excipients
- Known hypersensitivity or allergy to iodine or radio-opaque dyes
- Presence of asthma or other pulmonary disease, thyroid disease (hypo or hyperthyroidism), hepatitis, or other liver disease that would place the subject at increased risk from treatment with amiodarone, in the opinion of the investigator
- Myocardial infarction within the 30 days before Screening
- Functioning pacemaker at Screening or on Day 1
- Amiodarone administration within 7 days before dosing with trial drug
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- Cardiogenic shock, marked sinus bradycardia, or second- or third-degree atrioventricular block
- Any disease or condition that might compromise trial evaluations or place the subject at increased risk from treatment with amiodarone, in the opinion of the investigator
- Any clinically significantly abnormal laboratory test at Screening or Day 1 that would place the subject at increased risk from treatment with amiodarone, in the opinion of the investigator
- Women who are pregnant or breastfeeding A-ny subject who has received an investigational drug within 30 days before dosing with trial drug
- Inability to obtain 3 baseline SAP readings with no more than 5 mm Hg difference among these readings
About this study
The primary objective of this trial is to compare the relative hemodynamic effect of a novel intravenous formulation of amiodarone (PM101), administered as an immediate IV bolus push, with placebo and with the currentlyl available formulation of Amiodarone IV, administered as a 10-minute IV infusion, on systolic arterial pressure.
- Conditions
- Blood Pressure
- Being tested
- amiodarone
- Keywords
- Blood Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amiodaroneDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Control Receives: Drug: amiodarone |
| PM101 | Experimental | PM101 Receives: Drug: amiodarone |
| Amiodarone IV | Active comparator | Amiodarone IV Receives: Drug: amiodarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prism Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739193
- Sponsor's protocol ID
- 105
- Status last verified
- Sep 2017
- First submitted
- 20 Aug 2008
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Double Dummy Trial To Determine The Relative Effect Of Pm101 Versus Placebo And Amiodarone IV On Blood Pressure In Subjects With Stable Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00739193
- Acronym / sponsor ID
- 105
- Conditions
- Blood Pressure
- Keywords
- Blood Pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Prism PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 21 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to compare the relative hemodynamic effect of a novel intravenous formulation of amiodarone (PM101), administered as an immediate IV bolus push, with placebo and with the currentlyl available formulation of Amiodarone IV, administered as a 10-minute IV infusion, on systolic arterial pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: amiodaronePlacebo Control |
| PM101 | Experimental | Drug: amiodaronePM101 |
| Amiodarone IV | Active comparator | Drug: amiodaroneAmiodarone IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and women >18 years of age at Screening, with a diagnosis of stable congestive heart failure
- NYHA Functional Classification of Heart Failure Class II, III, or IV
- Documented left ventricular ejection fraction ≤35% within 6 months before Screening, provided that the assessment was not within 4 weeks of a myocardial infarction
- Outpatient or inpatient
- On stable doses of medications to treat congestive heart failure (eg, beta-blockers, angiotensin-converting enzyme inhibitor/angiotensin-receptor antagonist, diuretic) for at least 7 days before dosing with trial drug
Key exclusion criteria (11 listed)
- Known hypersensitivity or allergy to amiodarone, Captisol, Amiodarone IV, or any of its excipients
- Known hypersensitivity or allergy to iodine or radio-opaque dyes
- Presence of asthma or other pulmonary disease, thyroid disease (hypo or hyperthyroidism), hepatitis, or other liver disease that would place the subject at increased risk from treatment with amiodarone, in the opinion of the investigator
- Myocardial infarction within the 30 days before Screening
- Functioning pacemaker at Screening or on Day 1
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 |
|---|---|---|
| amiodarone | Drug | Amiodarone IV, PM101, Placebo |
Primary outcome
Systolic blood pressure
Time frame: 15 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing amiodarone in people with Blood Pressure, run by Prism Pharmaceuticals.
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 10 inclusion and 11 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: withdrawn, as of the sponsor's last update on 11 Sep 2017. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Systolic blood pressure (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2017; AzTrials last refreshed its copy on 30 Oct 2026.