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NCT01681095 · ClinicalTrials.gov registry record · Phase 2

Custodiol-HTK (Histidine-tryptophan-ketoglutarate) Solution as a Cardioplegic Agent

A Phase 2 study of Coronary Artery Disease and Heart Diseases, sponsored by Marc Sakwa, MD.

Completed
Registry status
Phase 2
Development phase
110
Enrollment target
1
Study location

NCT01681095 is a Phase 2 study of Coronary Artery Disease and Heart Diseases that has completed, run by Marc Sakwa, MD. The registered enrollment target is 110 participants, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01681095, a Phase 2 study of Coronary Artery Disease and Heart Diseases, has completed, sponsored by Marc Sakwa, MD.

COMPLETED
Registry status
Phase 2
Development phase
110 participants
Enrollment target
1
Study location

Study Summary

The purpose of the study is to demonstrate that Custodiol-HTK is not inferior to cold cardioplegic solution in patients undergoing cardiovascular surgery requiring cardioplegic arrest.

Interventions

  • DRUG Custodiol HTK
  • DRUG Cold Blood Cardioplegia

Study Locations (1)

Michigan

  • William Beaumont Hospital - Royal Oak

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2012-08
Est. Completion 2016-04
Phase Phase 2

Sponsor

Marc Sakwa, MD

1 total trials

What the Registry Record Tells You About NCT01681095

The ClinicalTrials.gov registry entry for NCT01681095 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (91% lower). The listed sponsor is Marc Sakwa, MD, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Custodiol HTK is the first listed.

NCT01681095 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.

Frequently Asked Questions

What is clinical trial NCT01681095 about?

NCT01681095 is a clinical study titled "Custodiol-HTK (Histidine-tryptophan-ketoglutarate) Solution as a Cardioplegic Agent". The purpose of the study is to demonstrate that Custodiol-HTK is not inferior to cold cardioplegic solution in patients undergoing cardiovascular surgery requiring cardioplegic arrest.

What is the current status of trial NCT01681095?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2012-08. Estimated completion is 2016-04.

What conditions does trial NCT01681095 study?

This clinical trial studies the following conditions: Coronary Artery Disease, Heart Diseases, Coronary Disease, Myocardial Ischemia, Valvular Heart Disease.

What interventions are being tested in trial NCT01681095?

The interventions under investigation include: Custodiol HTK (DRUG), Cold Blood Cardioplegia (DRUG).

Who is sponsoring clinical trial NCT01681095?

This trial is sponsored by Marc Sakwa, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01681095 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.