NCT01444651 is a Phase 3 clinical trial of Tadalafil in Cardiovascular Disease, sponsored by Thomas J. Wang, MD.

Who is sponsoring NCT01444651?

NCT01444651 is sponsored by Thomas J. Wang, MD.

What drugs are being tested in NCT01444651?

Interventions in NCT01444651: Tadalafil, Placebo.

What condition does NCT01444651 study?

NCT01444651 studies Cardiovascular Disease, Insulin Resistance, Glucose Intolerance, Obesity.

Is NCT01444651 still recruiting?

NCT01444651 is currently completed. Last updated 4 December 2016.

Are results published for NCT01444651?

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

Last reviewed 2016-12-04 · How we verify

NCT01444651

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

Phase 3 Randomized Trial of Tadalafil and Glycemic Traits

Completed Phase 3 Results posted Last updated 4 December 2016

What this trial tests

Phase 3 trial testing Tadalafil in Cardiovascular Disease in 73 participants. Completed in 1 March 2013.

Timeline

1 August 2011

Primary endpoint
1 March 2013

1 March 2013

Quick facts

Lead sponsor	Thomas J. Wang, MD
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	73
Start date	1 August 2011
Primary completion	1 March 2013
Estimated completion	1 March 2013
Sites	1 location across United States

Drugs / interventions tested

Tadalafil (tadalafil) — full drug profile →
Placebo

Conditions studied

Cardiovascular Disease — all drugs for Cardiovascular Disease →
Insulin Resistance — all drugs for Insulin Resistance →
Glucose Intolerance — all drugs for Glucose Intolerance →
Obesity — all drugs for Obesity →

Sponsor

Thomas J. Wang, MD

Who can join

Adults 18 to 50, any sex, with Cardiovascular Disease or Insulin Resistance. Healthy volunteers can join.

What's being measured

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

Change in Insulin Resistance From Baseline to 3 Months, as Measured by HOMA-IR
Time frame: Baseline and 3 months
The primary endpoint is defined as the treatment group difference in the change in insulin resistance (baseline HOMA-IR minus 3-month HOMA-IR). HOMA-IR = \[fasting glucose \* fasting insulin\]/405

Sponsor's own description

The purpose of this study is to find out if tadalafil can help overweight and obese people metabolize blood sugar more efficiently. The investigators also want to find out if 20 mg/day of tadalafil for 3 months is safe to take without causing too many side effects. The investigators are plan to enroll 100 subjects at Massachusetts General Hospital (MGH).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Established and emerging therapeutic uses of PDE type 5 inhibitors in cardiovascular disease.
Tzoumas N, Farrah TE, Dhaun N, Webb DJ. · · 2020 · cited 71× · PMID 31721165 · DOI 10.1111/bph.14920
Effect of phosphodiesterase inhibition on insulin resistance in obese individuals.
Ho JE, Arora P, Walford GA, Ghorbani A, et al · · 2014 · cited 26× · PMID 25213566 · DOI 10.1161/jaha.114.001001
Tadalafil and Steroid Hormones Interactions in Adipose, Bone and Prostate Tissues: Focus on Translational Perspectives.
Greco EA, Antinozzi C, Di Luigi L, Aversa A, et al · · 2022 · cited 1× · PMID 35457011 · DOI 10.3390/ijms23084191

Verify or expand the search:

Other trials of Tadalafil

Trials testing the same drug.

NCT07245680 — COMMODITIES Trial: Initial Dual Oral Therapy vs Monotherapy in PAH With Cardiovascular Comorbidities · Phase 3 · recruiting
NCT07312955 — Solifenacin Plus Tadalafil vs Solifenacin Alone for Overactive Bladder in Females · NA · completed
NCT05937854 — Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH · Phase 2 · recruiting
NCT06466369 — Administration of Tadalafil in Patients With Benign Prostatic Hyperplasia · Phase 3 · completed
NCT06213077 — The Effects of a Nitrate Supplementation on Erectile Function · NA · unknown

Other recruiting trials for Cardiovascular Disease

Currently open trials in the same condition.

NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors · NA · recruiting
NCT07293260 — Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction - Coronary Computed Tomography Angiography Trial · Phase 3 · recruiting
NCT07497932 — Nutritional Effects in Cardiovascular Surgery · NA · recruiting
NCT06625073 — Randomized Trial of SGLT2i in Heart Transplant Recipients · Phase 4 · recruiting
NCT06485700 — Peers and Technology for Adherence, Access, Accountability, and Analytics (PT4A) · NA · 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 NCT01444651 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Thomas J. Wang, MD
Last refreshed: 4 December 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/NCT01444651.

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