NCT04251364

Brief Summary

This study aims to assess the effect of two drugs for the treatment of chronic mountain sickness in highlanders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

February 15, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

1.7 years

First QC Date

January 29, 2020

Last Update Submit

July 29, 2025

Conditions

Hypoxia, Altitude

Outcome Measures

Primary Outcomes (1)

  • Change in hematocrit

    Change in blood hematocrit value in percentage

    Change from before to after 9 months of treatment

Secondary Outcomes (7)

  • Chronic mountain sickness score

    Change from before to after 9 months of treatment

  • Macrovascular reactivity

    Change from before to after 9 months of treatment

  • Microvascular reactivity

    Change from before to after 9 months of treatment

  • Hemoglobin mass

    Change from before to after 9 months of treatment

  • Pulmonary arterial pressure

    Change from before to after 9 months of treatment

  • +2 more secondary outcomes

Study Arms (3)

Acetazolamide

EXPERIMENTAL

Oral acetazolamide (250 mg/day) intake for 9 months

Drug: Acetazolamide

Atorvastatin

EXPERIMENTAL

Oral atorvastatin (40 mg/day) intake for 9 months

Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR

Oral placebo pill (daily) intake for 9 months

Drug: Placebo oral tablet

Interventions

AcetazolamideDRUG

Daily acetazolamide pill intake

Also known as: Diamox
Acetazolamide
AtorvastatinDRUG

Daily atorvastatin pill intake

Atorvastatin
Placebo oral tabletDRUG

Daily placebo pill intake

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Age between 18 and 55 yrs
  • Body mass index \<30kg/m²
  • Born at \>3500 m, living for \>3 years at the local high altitude
  • No diagnosis of cardiorespiratory, metabolic or neurological diseases
  • No drug intake
  • No smoker
  • Chronic mountain sickness score ≥6

You may not qualify if:

  • Diagnosis of cardiorespiratory, metabolic and neurological diseases
  • Systolic \> 130 mmHg and/or diastolic \> 85 mmHg blood pressure
  • Drug intake
  • Smoker
  • Chronic mountain sickness score \<6

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Association EXALT, UM Sport Pathologies, Hôpital Sud, Avenue Kimberley

Échirolles, 38130, France

Location

MeSH Terms

Conditions

Altitude Sickness

Interventions

AcetazolamideAtorvastatin

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ThiadiazolesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolesHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Samuel Verges, PhD

    EXAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2020

First Posted

January 31, 2020

Study Start

February 15, 2020

Primary Completion

October 30, 2021

Study Completion

December 30, 2021

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)