NCT01386983 is a clinical trial of 5ARI in Prostatic Hyperplasia, sponsored by GlaxoSmithKline.

Who is sponsoring NCT01386983?

NCT01386983 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01386983?

Interventions in NCT01386983: 5ARI, 5ARI + AB.

What condition does NCT01386983 study?

NCT01386983 studies Prostatic Hyperplasia.

Is NCT01386983 still recruiting?

NCT01386983 is currently completed. Last updated 15 May 2017.

Are results published for NCT01386983?

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

Last reviewed 2017-05-15 · How we verify

NCT01386983

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

Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment

Completed Results posted Last updated 15 May 2017

What this trial tests

trial testing 5ARI in Prostatic Hyperplasia in 332 participants. Completed in 1 June 2010.

Timeline

1 March 2009

Primary endpoint
1 June 2010

1 June 2010

Quick facts

Lead sponsor	GlaxoSmithKline
Status	Completed
Study type	OBSERVATIONAL
Enrollment	332
Start date	1 March 2009
Primary completion	1 June 2010
Estimated completion	1 June 2010

Drugs / interventions tested

5ARI — full drug profile →
5ARI + AB — full drug profile →

Conditions studied

Prostatic Hyperplasia — all drugs for Prostatic Hyperplasia →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

50 and older, male only, with Prostatic Hyperplasia. 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.

Number of Participants With Clinical Progression
Time frame: 3 months prior to and 12 months following index date
Participants with clinical progression are defined as those with acute urinary retention and/or receiving prostate-related surgery.

Sponsor's own description

This retrospective study aims to assess the clinical and economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI monotherapy or combination therapy with an alpha-blocker (AB) compared to late initiation of 5ARI therapy in patients receiving combination therapy. The Henry Ford Health System databases will be utilized for this study (2000-2008).

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 Prostatic Hyperplasia

Currently open trials in the same condition.

NCT06242119 — Clinical Application of the J-PET Scanner Prototype · recruiting
NCT06161506 — Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer · Phase 2 · recruiting
NCT06209307 — Pelvic Floor Physical Therapy to Reduce Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate · NA · active not recruiting
NCT06001619 — Prostate Medication, Metabolism and Gut Microbiota · Phase 4 · recruiting
NCT03354416 — Profiling of Radiological Factors in Treatment and Outcomes in Prostate Cancer · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · 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 NCT01386983 (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 GlaxoSmithKline
Last refreshed: 15 May 2017

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/NCT01386983.

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