HypertensionPhase 3NCT05195827
Effect of PRM-125 on Ambulatory Blood Pressure
A Phase 3 study testing PRM-125 in people with Hypertension, run by PRM Pharma, LLC at 1 site in United States.
Trial summary
Evaluation of Once-Daily PRM125 On Ambulatory Blood Pressure in Adults with Hypertension Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- PRM-125
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2021to 30 Nov 2022
- Phase
- Phase 3
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary hypertension
Who cannot join
- medical conditions that preclude evaluation and/or adversely effect subject safety
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Once-Daily PRM125 On Ambulatory Blood Pressure in Adults With Hypertension
Evaluation of Once-Daily PRM125 On Ambulatory Blood Pressure in Adults with Hypertension
Read the detailed description
Approximately 60 subjects with primary hypertension are treated for 8 weeks with PRM125 to determine if Ambulatory Blood Pressure is changed.
- Conditions
- Hypertension
- Being tested
- PRM-125
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRM-125Drug
Antihypertensive
| Study group | Role | What they receive |
|---|---|---|
| PRM125 | Experimental | PRM125 Receives: Drug: PRM-125 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24 hour Systolic Blood Pressure
Measured: 8 weeks
Secondary outcomes (1)
Change in 24 hour Diastolic Blood Pressure
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start20 Dec 2021
- Primary completion30 Sep 2022
- Study completion30 Nov 2022
Why it stopped: Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- PRM Pharma, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195827
- Sponsor's protocol ID
- CTD-3001
- Status last verified
- Mar 2023
- First submitted
- 2 Jan 2022
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Once-Daily PRM125 On Ambulatory Blood Pressure in Adults With Hypertension
- ClinicalTrials.gov ID
- NCT05195827
- Acronym / sponsor ID
- CTD-3001
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PRM Pharma, LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 19 Jan 2022 (actual)
- 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.
Evaluation of Once-Daily PRM125 On Ambulatory Blood Pressure in Adults with Hypertension
Detailed description
Approximately 60 subjects with primary hypertension are treated for 8 weeks with PRM125 to determine if Ambulatory Blood Pressure is changed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRM125 | Experimental | Drug: PRM-125PRM125 |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary hypertension
Key exclusion criteria (1 listed)
- medical conditions that preclude evaluation and/or adversely effect subject safety
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 |
|---|---|---|
| PRM-125Antihypertensive | Drug | PRM125 |
Primary outcome
Change in 24 hour Systolic Blood Pressure
Time frame: 8 weeks
1 secondary outcome
Change in 24 hour Diastolic Blood Pressure
Time frame: 8 weeks
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 20 Mar 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PRM-125 in people with Hypertension, run by PRM Pharma, LLC at 1 site in United States.
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 1 inclusion and 1 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 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in 24 hour Systolic Blood Pressure (time frame: 8 weeks). 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 20 Mar 2023.