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The Role of Endothelin-1 in Sickle Cell Disease

NCT02712346 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-04-02

No results posted yet for this study

Summary

The primary goal of the study is to determine the safety and tolerability of ambrisentan. It is also expected that ambrisentan will improve blood flow in the lungs, decrease inflammation, and reduce pain in sickle cell patients. An additional goal is to evaluate the use of select biomarkers in evaluating sickle nephropathy.

Conditions

Interventions

DRUG

Ambrisentan

Ambrisentan 5 milligrams a day or a placebo (sugar pill) for twelve weeks

DRUG

Placebo

One inactive pill daily for twelve weeks

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Augusta University

    lead OTHER

Principal Investigators

  • Abdullah Kutlar, MD · Augusta University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-05-30
Completion
2019-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02712346 on ClinicalTrials.gov