Who is sponsoring NCT01181232?

NCT01181232 is sponsored by Astellas Pharma Inc.

What drugs are being tested in NCT01181232?

Interventions in NCT01181232: Zolpidem MR, Zolpidem IR.

What condition does NCT01181232 study?

NCT01181232 studies Sleep Initiation and Maintenance Disorders, Primary Insomnia.

Is NCT01181232 still recruiting?

NCT01181232 is currently completed. Last updated 9 September 2014.

Last reviewed 2014-09-09 · How we verify

NCT01181232

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

A Randomized, Active Control, Parallel Study to Evaluate the Efficacy and Safety of Zolpidem MR (Stilnox CR) Versus Zolpidem (Stilnox) in Patients With Primary Insomnia

Completed Phase 4 Last updated 9 September 2014

What this trial tests

Phase 4 trial testing Zolpidem MR in Sleep Initiation and Maintenance Disorders in 132 participants. Completed in 1 April 2011.

Timeline

1 October 2009

Primary endpoint
1 April 2011

1 April 2011

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	132
Start date	1 October 2009
Primary completion	1 April 2011
Estimated completion	1 April 2011
Sites	2 locations across Taiwan

Drugs / interventions tested

Zolpidem MR — full drug profile →
Zolpidem IR — 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.

Rest/activity cycles measured by Actigraphy
Time frame: For 2 weeks (Day 0, Day 7, Day 14)
Total score of Pittsburgh Sleep Quality Index (PSQI)
Time frame: For 2 weeks (Day 0, Day 7, Day 14)

Sponsor's own description

The purpose of this study is to investigate the efficacy and safety of zolpidem MR (modified release) compared to zolpidem IR (immediate release) 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 NCT01181232 (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: 9 September 2014

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/NCT01181232.

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