NCT00627965

Brief Summary

The purpose of this study is to determine whether regular oral use of sildenafil citrate can prevent or attenuate high altitude illnesses.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_4

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

Study Start

First participant enrolled

March 1, 2003

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2008

Completed
Last Updated

March 4, 2008

Status Verified

February 1, 2008

First QC Date

February 24, 2008

Last Update Submit

February 24, 2008

Conditions

High Altitude Pulmonary EdemaAcute Mountain Sickness

Keywords

Sildenafil citratePreventionHigh Altitude Pulmonary EdemaAcute Mountain SicknessHealthy Lowland SubjectsPulmonary Artery Systolic Pressure

Outcome Measures

Primary Outcomes (1)

  • Pulmonary Artery Systolic Pressure (PASP)

Study Arms (2)

1

EXPERIMENTAL

Sildenafil citrate

Drug: Sildenafil citrate

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Sildenafil citrateDRUG

50mg tds

1
PlaceboDRUG

Placebo tds

2

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participant in Apex 2 high altitude expedition

You may not qualify if:

  • Previous history of high altitude pulmonary edema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • MacCormick IJ, Somner J, Morris DS, MacGillivray TJ, Bourne RR, Huang SS, MacCormick A, Aspinall PA, Baillie JK, Thompson AA, Dhillon B. Retinal vessel tortuosity in response to hypobaric hypoxia. High Alt Med Biol. 2012 Dec;13(4):263-8. doi: 10.1089/ham.2011.1097.

    PMID: 23270443DERIVED

  • Bates MG, Thompson AA, Baillie JK, Sutherland AI, Irving JB, Hirani N, Webb DJ. Sildenafil citrate for the prevention of high altitude hypoxic pulmonary hypertension: double blind, randomized, placebo-controlled trial. High Alt Med Biol. 2011 Fall;12(3):207-14. doi: 10.1089/ham.2011.0007.

    PMID: 21962063DERIVED

Related Links

MeSH Terms

Conditions

Altitude Sickness

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Matthew Bates

    Altitude Physiology Expeditions

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 24, 2008

First Posted

March 4, 2008

Study Start

March 1, 2003

Study Completion

February 1, 2008

Last Updated

March 4, 2008

Record last verified: 2008-02