Who is sponsoring NCT00956319?

NCT00956319 is sponsored by Astellas Pharma Inc.

What drugs are being tested in NCT00956319?

Interventions in NCT00956319: Zolpidem MR, Estazolam.

What condition does NCT00956319 study?

NCT00956319 studies Sleep Initiation and Maintenance Disorders, Primary Insomnia.

Is NCT00956319 still recruiting?

NCT00956319 is currently completed. Last updated 5 October 2011.

Last reviewed 2011-10-05 · How we verify

NCT00956319

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

A Randomized, Open-Label, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Zolpidem Modified Release (MR) in Patients With Primary Insomnia

Completed Phase 4 Last updated 5 October 2011

What this trial tests

Phase 4 trial testing Zolpidem MR in Sleep Initiation and Maintenance Disorders in 42 participants. Completed in 1 November 2010.

Timeline

1 May 2009

Primary endpoint
1 November 2010

1 November 2010

Quick facts

Lead sponsor	Astellas Pharma Inc
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	1 May 2009
Primary completion	1 November 2010
Estimated completion	1 November 2010
Sites	1 location across Taiwan

Drugs / interventions tested

Zolpidem MR — full drug profile →
Estazolam (ESTAZOLAM) — full drug profile →

Conditions studied

Sleep Initiation and Maintenance Disorders — all drugs for Sleep Initiation and Maintenance Disorders →
Primary Insomnia — all drugs for Primary Insomnia →

Sponsor

Astellas Pharma Inc — full company profile →

Who can join

Adults 18 to 64, any sex, with Sleep Initiation and Maintenance Disorders or Primary Insomnia. 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.

Total score of Pittsburgh Sleep Quality Index (PSQ)
Time frame: 3 weeks

Sponsor's own description

The purpose of the study is to investigate the efficacy and safety of zolpidem modified release (MR) tablet using estazolam (Eurodin) as a comparative drug in patients with primary insomnia.

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 Sleep Initiation and Maintenance Disorders

Currently open trials in the same condition.

NCT06744673 — A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control P · active not recruiting
NCT05000528 — Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia · NA · recruiting
NCT03642028 — Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress · Phase 4 · recruiting
NCT04598672 — Cognitive Behavioral Therapy for Insomnia (CBTi) in Patients With Somatic Disease · NA · active not recruiting

Other Astellas Pharma Inc trials

Trials by the same sponsor.

NCT07318714 — A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke · Phase 1, PHASE2 · recruiting
NCT07094204 — A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors · Phase 1 · recruiting
NCT06970665 — A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Ma · Phase 4 · recruiting
NCT06364696 — A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors · Phase 1 · active not recruiting
NCT06206421 — A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause · Phase 3 · completed

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 NCT00956319 (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 Astellas Pharma Inc
Last refreshed: 5 October 2011

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/NCT00956319.

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