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NCT00435331 · ClinicalTrials.gov registry record · Phase 1
6R-BH4 Pulmonary Arterial Hypertension Study
A Phase 1 study, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT00435331 is a Phase 1 study that has completed, run by Vanderbilt University. The registered enrollment target is 14 participants.
The verdict
NCT00435331, a Phase 1 study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether the addition of sapropterin dihydrochloride (6R-BH4) to existing treatment has any effect in patients with pulmonary arterial hypertension (PAH). Patients with PAH have low levels of a substance called nitric oxide (NO). Tetrahydrobiopterin (BH4) is a substance produced by the body that is an essential requirement in the formation of NO. NO is thought to be helpful in keeping blood vessels in the lung healthy. 6R-BH4 is an experimental (unproven) medicine made in the lab that is very much like the BH4 that our own body makes. The researchers are investigating whether 6R-BH4 can be added safely to current treatment for PAH and whether there is any evidence of benefit from its use. The study will take approximately one year to complete from the time recruitment begins. The primary objective of the study is to evaluate the safety of oral 6R-BH4, administered in escalating doses in addition to standard care, in subjects with pulmonary arterial hypertension (PAH). The secondary objective of the study is to evaluate change in biochemical markers of endothelial dysfunction and nitric oxide synthetase activity (coupled and uncoupled) in subjects with PAH receiving escalating doses of oral 6R-BH4 in addition to standard care. The third objective of the study is to evaluate change in biomarkers of disease progression, 6-minute walk (6MW) distance, Borg dyspnea scores, and quality of life (QOL) measures in subjects with PAH receiving escalating doses of oral 6R-BH4 in addition to standard care.
Interventions
- DRUG sapropterin dihydrochloride (6R-BH4)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2008-03 |
| Est. Completion | 2008-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00435331
The ClinicalTrials.gov registry entry for NCT00435331 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which sapropterin dihydrochloride (6R-BH4) is the first listed.
NCT00435331 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00435331 about?
NCT00435331 is a clinical study titled "6R-BH4 Pulmonary Arterial Hypertension Study". The purpose of this study is to determine whether the addition of sapropterin dihydrochloride (6R-BH4) to existing treatment has any effect in patients with pulmonary arterial hypertension (PAH). Patients with PAH have low levels of a substance called nitric oxide (NO). Tetrahydrobiopterin (BH4) is ...
What is the current status of trial NCT00435331?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2008-03. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00435331?
The interventions under investigation include: sapropterin dihydrochloride (6R-BH4) (DRUG).
Who is sponsoring clinical trial NCT00435331?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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