Trial intelligence / Profile preview

HighCycle: Acetazolamide Effect on Plasma Volume at High Altitude

NCT07118462Phase 4

Key facts

Status
Recruiting
Start
Jul 2024
Primary completion
Dec 2025
Countries
1
Sponsor
EXALT
Modality
Small Molecules
Conditions
acute mountain sickness (AMS)
01

Overview

Phase 4, randomised, double-blind trial in acute mountain sickness (AMS) comparing Acetazolamide with Placebo (2 arms). Primary endpoint: Plasma volume at Day 3. Started Jul 2024; status: recruiting.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Acetazolamide

    Acetazolamide 250 mg/day (125 mg BID)

  • Placebo

    Placebo capsules (BID)

03

Endpoints

Primary

  • Plasma volume

Secondary

  • Plasma volume : sex-related difference

  • Plasma volume : AMS-related difference

  • Hormones

  • Arterial blood gases

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