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OBPM_Meds2023: Multicentric Prospective Clinical Study to Evaluate the Aktiia Optical Blood Pressure Monitoring (OBPM) Device Compared to Standard Home Blood Pressure Monitoring (HBPM) in Hypertensive Patients When Blood Pressure Lowering Medications Intake

Study acronym: OBPM_Meds2023
StatusRecruiting
PhaseNot applicable
SponsorAktiia SA
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 2 to 3 Eligibility criteria expanded, about 17 wordsv8 Show 1 more changeShow less
    • Eligibility criteria expanded, about 17 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026 Study title expanded, about 1 wordv7 Show 1 more changeShow less
    • Study title expanded, about 1 word

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  3. Primary and study completion dates: May 29, 2025 to Dec 31, 2025 Enrollment target: 25 to 35 · Interventions: Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (Other) to Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy and bitherapy) (Other), Aktiia Optical Blood… · Eligibility criteria expanded, about 83 words · 4 morev6 Show 7 more changesShow less
    • Enrollment target: 25 to 35
    • Interventions: Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (Other) to Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy and bitherapy) (Other), Aktiia Optical Blood…
    • Eligibility criteria expanded, about 83 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study description expanded, about 106 words
    • Site details revised at 1 of 2 sites
    • Study arms: 1 to 3

    See this version in full on ClinicalTrials.gov ↗

  4. Primary and study completion dates: May 29, 2024 to May 29, 2025v5
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Primary and study completion dates: Feb 29, 2024 to May 29, 2024 · Eligibility criteria expanded, about 27 wordsv4 Show 3 more changesShow less
    • Study sites: 0 to 2
    • Primary and study completion dates: Feb 29, 2024 to May 29, 2024
    • Eligibility criteria expanded, about 27 words

    See this version in full on ClinicalTrials.gov ↗

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  1. Eligibility criteria expanded, about 11 words Study description expanded, about 31 wordsv3 Show 1 more changeShow less
    • Study description expanded, about 31 words

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Apr 30, 2023 to Jun 29, 2023 Primary and study completion dates: Sep 15, 2023 to Feb 29, 2024v2 Show 1 more changeShow less
    • Primary and study completion dates: Sep 15, 2023 to Feb 29, 2024
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Aktiia SA
9 trials monitored
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Hypertension
1,795 trials monitored
See 85 trials at risk
Study design: Prospective, multicentric, randomized, comparative study Study duration: between 4 and 19 weeks depending on the study group. Population: minimum 35 hypertensives (stage 1 or stage 2) participants divided into 3 groups depending on hypertension criteria. GROUP 1 = untreated hypertensives, stage 1 or stage 2; GROUP 2 = hypertensives, stage 1, who are taking antihypertensive monotherapy; GROUP 3 = hypertensives, stage 1 or stage 2, who are taking antihypertensive treatment that doesn't allow them to have controlled blood pressure. Device Under Test (DUT): Aktiia device Reference: HBPM (Aktiia cuff) Periods of treatment: For GROUPS 1 and 2, 2 weeks of treatment for each antihypertensive medication followed by a washout period of 2 weeks (3 antihypertensive medications in total with a fixed dose; medication intake order is randomly assigned). For GROUP 3, an individualized new antihypertensive medication will be prescribed during the consultation with the investigator that will be administered for 3 weeks.
Trial Details
NCT Number NCT05780710
Lead Sponsor Aktiia SA
Conditions Hypertension
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov