To Evaluate the Safety and Efficacy of MANP in Subjects With Difficult to Control/ Resistant Hypertension

Study acronym: BOLD-HTN
StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Jul 1, 2026 → Jul 1, 2027
See other at-risk trials from E-Star BioTech, LLC

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jul 1, 2026 to Jul 1, 2027
    • Trial sites reduced: 29 → 23 locations
    • Study completion pushed from Sep 1, 2026 to Sep 30, 2027
    • Eligibility criteria expanded, about 20 words
  2. Primary completion date: Sep 1, 2025 to Jul 1, 2026
    • Study sites: 21 to 29
    • Study completion date: Dec 1, 2025 to Sep 1, 2026
    v11
  3. Study sites: 8 to 21v10
  4. Study sites: 5 to 8v9
  5. Enrollment target: 132 to 120
    • Study sites: 2 to 5
    • Start date changed from estimate of Nov 2024 to Nov 17, 2024
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Trial status: Not Yet Recruiting to Recruitingv7 Show 4 more changesShow less
    • Start date: Sep 25, 2024 to Nov 2024
    • Study sites: 0 to 2
    • Primary completion date: Aug 1, 2025 to Sep 1, 2025
    • Study completion date: Sep 1, 2025 to Dec 1, 2025
  2. Start date: Aug 1, 2024 to Sep 25, 2024v6
  3. Re-verified, no change to tracked fieldsv5
  4. Start date: Jul 1, 2024 to Aug 1, 2024
    • Primary completion date: Jul 1, 2025 to Aug 1, 2025
    • Study completion date: Aug 1, 2025 to Sep 1, 2025
    v4
  5. 2 versions Re-verified since Apr 4, 2024, no change to tracked fieldsv2-v3
  1. Study First Submitted
  • 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.
This is a Phase 2 dose-titration study designed to evaluate the safety and efficacy of MANP subcutaneous injection compared to placebo in reducing baseline daytime systolic blood pressure (SBP), derived from 24-hour ambulatory blood pressure monitoring (ABPM), in subjects with hypertension who are taking 3 or more antihypertensive medications with different mechanisms of action.
Trial Details
NCT Number NCT06343298
Lead Sponsor E-Star BioTech, LLC
Collaborators: Mayo Clinic, PPD Development, LP
Conditions
(from sponsor)		 Difficult to Control Hypertension
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov