CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 42 enrolled
Drug / intervention
N-acetylcysteine +1 moredrug
Likely dose
N-acetylcysteine 600mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01537926
NCT01537926Phase 1Completed

Pilot Feasibility Study With N-acetylcystein (NAC) in Patients With HCM Caused by Sarcomere Proteins Mutations

The University of Texas Health Science Center, Houston·interventional·Posted Feb 23, 2012·Updated Nov 2, 2021

In Brief

A Phase 1 clinical trial evaluating N-acetylcysteine and Placebo for Hypertrophic Cardiomyopathy. Completed, enrolled 42 participants across 1 site.

Detailed Summary

The purpose of the sudy is to conduct a small study to gather the preliminary data for future lage scale clinical studies that will be designed test the potential beneficial effect of over-the counter study anti-oxidant drug called N-acetylcysteine (NAC) in patients with a heart muscle condition called Hypertrophic Cardiomyopathy (HCM). The present study is a pilot feasibility study, the investigators want to find out whether the investigators can recruit and retain patients with HCM in the study and whether these patients can tolerate this drug and can stay on one year. Likewise, the investigators want to find out any potential side effects that this drug might have and estimate whether it has any beneficial effects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 23, 2012
Enrollment StartJan 1, 2012
Primary CompletionDec 31, 2016
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 14.4 years ago

Interventions

N-acetylcysteinedrug

NAC 600mg capsule or matching Placebo , 1 twice daily for 90 days, then increase to NAC 1,200mg or matching placebo, 2 capsules twice daily for 270 days.

Placebodrug

sugar pill manufactured to minic NAC 600mg capsule