NCT00413244 is a Phase 3 clinical trial of AndroGel 5 Grams in Coronary Artery Disease, sponsored by Icahn School of Medicine at Mount Sinai.

Who is sponsoring NCT00413244?

NCT00413244 is sponsored by Icahn School of Medicine at Mount Sinai.

What drugs are being tested in NCT00413244?

Interventions in NCT00413244: AndroGel 5 Grams, Placebo.

What condition does NCT00413244 study?

NCT00413244 studies Coronary Artery Disease.

Is NCT00413244 still recruiting?

NCT00413244 is currently completed. Last updated 7 November 2016.

Are results published for NCT00413244?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2016-11-07 · How we verify

NCT00413244

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Cardiac Benefit of Androgen Replacement in Hypogonadal Males With Coronary Artery Disease Following Successful Percutaneous Coronary Intervention (PCI).

Completed Phase 3 Results posted Last updated 7 November 2016

What this trial tests

Phase 3 trial testing AndroGel 5 Grams in Coronary Artery Disease in 51 participants. Completed in 1 November 2014.

Timeline

1 January 2007

Primary endpoint
1 January 2014

1 November 2014

Quick facts

Lead sponsor	Icahn School of Medicine at Mount Sinai
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	51
Start date	1 January 2007
Primary completion	1 January 2014
Estimated completion	1 November 2014
Sites	1 location across United States

Drugs / interventions tested

AndroGel 5 Grams — full drug profile →
Placebo

Conditions studied

Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

Adults 40 to 75, male only, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Cardiac Stress Test: Time to ST Depression
Time frame: at 6 months
Treadmill exercise testing performed according to the Bruce protocol (MAX-1 Marquette advanced exercise system, software version 002E). The system analyzed the signal averaged ECG and produces a graphical display of the level of the ST segment 80 ms after the J point against time. Time to 1 mm ST depression was measured from computer derived analysis, effectively eliminating observer bias.
Cardiac Stress Testing: Exercise Capacity
Time frame: At 1 month, 3 months, and 6 months
Exercise capacity was measured using exercise time.

Sponsor's own description

The purpose of the study is to find out if giving the study drug, Androgel (testosterone) as a testosterone replacement help bring the testosterone to an acceptable level and to find out if it will help improve heart condition in males with coronary artery disease (CAD) following successful percutaneous coronary intervention.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Coronary Artery Disease

Currently open trials in the same condition.

NCT07399002 — LONG NAGOMI™ PMCF STUDY · recruiting
NCT07420582 — Antegrade Autologous Blood Reinfusion After CPB · recruiting
NCT07493603 — A Study on Yiyang Huoluo Decoction in the Treatment of Coronary Heart Disease · Phase 1, PHASE2 · recruiting
NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO · NA · recruiting
NCT07286578 — A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Under · NA · recruiting

Other Icahn School of Medicine at Mount Sinai trials

Trials by the same sponsor.

NCT07094308 — The LIFT-ECHO Last Mile Project · NA · not yet recruiting
NCT07291427 — Chronic Subdural Hematoma Embolization With Detachable Coils · not yet recruiting
NCT07194187 — High Intensity Focused Ultrasound (HIFU) Ablation for Treatment of Prostate Tissue in Bladder Outlet Obstruction · NA · not yet recruiting
NCT07260916 — Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation · NA · not yet recruiting
NCT07487948 — Safety and Biomarker Responses of Delgocitinib (JAK1,2,3/TYK2 Inhibitor) in Central Centrifugal Cicatricial Alopecia and · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00413244 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai
Last refreshed: 7 November 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00413244.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing