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Efficacy and Safety of Butylphthalide Soft Capsule for the Treatment of Vascular Dementia

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Study completion date: Feb 7, 2025 to Jun 7, 2026v13
  2. Enrollment target: estimated 700 to confirmed 707
    • Primary completion date changed from estimate of Oct 31, 2024 to Oct 23, 2024
    • Study completion date: Dec 31, 2024 to Feb 7, 2025
    v12
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v11
  4. Re-verified, no change to tracked fieldsv10
  5. Primary completion date: Dec 31, 2022 to Oct 31, 2024
    • Study completion date: Apr 1, 2023 to Dec 31, 2024
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Primary completion date: Dec 31, 2021 to Dec 31, 2022
    • Study completion date: Feb 1, 2022 to Apr 1, 2023
    • Eligibility criteria expanded, about 81 words
    v8
  2. Eligibility criteria shortened, about 21 wordsv7
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 15, 2019 to Oct 29, 2019
    • Eligibility criteria expanded, about 22 words
    • Site details revised
    v6
  4. Start date: Apr 30, 2019 to May 15, 2019v5
  5. Re-verified, no change to tracked fieldsv4
  6. Start date: Mar 15, 2019 to Apr 30, 2019
    • Eligibility criteria expanded, about 3 words
    v3
  7. Secondary endpoints: details revised at 4 of 8 entries
    • Study description expanded, about 1 word
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Butylphthalide soft capsule has been confirmed to have beneficial effects for patients with vascular dementia (VaD) in clinical trial of phase II study. So the investigators hypothesize that Butylphthalide soft capsule may have same beneficial effects for patients with VaD in an extended samples in phase III study. In present study the investigators will recruit patients with mild to moderate VaD in a multi-center, random, double blind and placebo control methods to confirm the efficacy and safety of Butylphthalide soft capsule. The outcome measures include general cognitive function, executive function, daily living skills, and mental behavior changes of symptoms in VaD patients.
Trial Details
NCT Number NCT03804229
Lead Sponsor Capital Medical University
Collaborators: CSPC-NBP Pharmaceutical Co., Ltd.
Conditions
(from sponsor)		 Vascular Dementia
Related terms Dementia, Vascular
Enrollment 707 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov