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Anti-metabolites

Artesunate for Pulmonary Arterial Hypertension ((STOP-PAH) Trial)

Stanford, CA
Phase 1
Waitlist Available
Research Sponsored by Joseph C. Wu
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
WHO functional class I, II/III despite treatment with maximally tolerated doses of 2 or more treatment modalities including PDE5 inhibitors, guanylate cyclase stimulators, endothelin receptor antagonists, and prostanoids when appropriate.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is a 20-week study that is testing the safety and tolerance of a medication called artesunate in patients with pulmonary arterial hypertension.

See full description
Who is the study for?
This trial is for patients with Pulmonary Arterial Hypertension (PAH). Specific eligibility criteria are not provided, but typically participants would need to have a confirmed diagnosis of PAH and be in stable condition to participate.Check my eligibility
What is being tested?
The study is testing the safety and how well people can tolerate different doses of an oral medication called Artesunate. It's a Phase 1 trial that lasts for 20 weeks at a single center where everyone knows what treatment they're getting.See study design
What are the potential side effects?
Since this is a safety and tolerability study, side effects are being closely monitored. Common side effects of Artesunate may include headache, dizziness, anemia, or gastrointestinal issues like nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My heart and lung condition is stable even after taking various treatments.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2012 Phase 3 trial • 640 Patients • NCT00379821
80%
Nasopharyngitis
29%
Impetigo
29%
Gastroenteritis
26%
Diarrhoea
23%
Pneumonia
19%
Pyrexia
17%
Conjunctivitis
16%
Haemorrhagic anaemia
16%
Cough
14%
Tinea capitis
11%
Dysentery
11%
Varicella
11%
Rash papular
9%
Body tinea
8%
Otitis media
8%
Abdominal pain
7%
Thrombocytopenia
6%
Excoriation
6%
Thermal burn
6%
Rash pruritic
5%
Helminthic infection
5%
Parotitis
5%
Oral herpes
4%
Stomatitis
4%
Alanine aminotransferase increased
3%
Pruritus
3%
Vomiting
1%
Rectal prolapse
1%
Pneumonia primary atypical
1%
Febrile convulsion
1%
Neutropenia
1%
Bronchitis
1%
Malnutrition
1%
Conjunctivitis bacterial
1%
Inguinal hernia
1%
Malaria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chloroquine Plus Artesunate
Chloroquine Plus Atovaquone-Proguanil
CQ Plus Azithromycin
CQ Monotherapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open Label Treatment ArmExperimental Treatment1 Intervention
Dose escalating study with a Follow-up (washout) Period:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Artesunate
2005
Completed Phase 4
~3950

Find a Location

Closest Location:Stanford University· Stanford, CA

Who is running the clinical trial?

Joseph C. WuLead Sponsor
2 Previous Clinical Trials
28 Total Patients Enrolled
Roham Zamanian, MDStudy DirectorStanford University
3 Previous Clinical Trials
110 Total Patients Enrolled
3 Trials studying Pulmonary Arterial Hypertension
110 Patients Enrolled for Pulmonary Arterial Hypertension
~10 spots leftby Jan 2029
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