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Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia - Eligibility

- 9/27/21 - 1 form, 2 itemgroups, 51 items, 2 languages
Itemgroups: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT00247390

Eligibility Sleep Initiation and Maintenance Disorders NCT00227942

- 9/20/21 - 1 form, 2 itemgroups, 15 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Estrogen for Treating Depression in Menopausal Women With Hot Flashes and Insomnia; ODM derived from: https://clinicaltrials.gov/show/NCT00227942

Eligibility Excessive Daytime Sleepiness NCT00642928

- 9/17/21 - 1 form, 2 itemgroups, 18 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Dose Range Finding Study of BF2.649 Versus Placebo to Treat Excessive Daytime Sleepiness in Parkinson's Disease Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00642928

Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597 - Romberg Test and Heel-To-Toe Test

- 11/15/19 - 1 form, 2 itemgroups, 6 items, 1 language
Itemgroups: Administrative, Rhomberg Test and Heel-To-Toe Test
Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders

Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597 - Concomitant Medications; Non-serious Adverse Events; Serious Adverse Events

- 11/15/19 - 1 form, 18 itemgroups, 72 items, 1 language
Itemgroups: Administrative, Concomitant Medications, Concomitant Medications , Non-Serious adverse Events, Non-Serious adverse Events , Serious Adverse Event, Serious Adverse Event - Section 1, Serious Adverse Event - Section 2 Seriousness, Serious Adverse Event - Section 3 Demography Data, Serious Adverse Event - Section 4, Serious Adverse Event - Section 5 Possible Causes of SAE Other Than Investigational Product(s), Serious Adverse Event - Section 6 Relevant medical Conditions, Serious Adverse Event - Section 7 Other relevant Risk Factors, Serious Adverse Event - Section 8 Relevant Concomitant Medications, Serious Adverse Event - Section 9 Details of Investigational Product(s), Serious Adverse Event - Section 10 Details of relevant Assessments, Serious Adverse Event - Section 11 Narrative Remarks, Investigator's signature
Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders

Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597 - Screening - 12-Lead ECG Abnormalities

- 11/15/19 - 1 form, 3 itemgroups, 16 items, 1 language
Itemgroups: Administrative, 12-Lead ECG Abnormalities, 12-Lead ECG Abnormalities
Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders

Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597 - Screening - Eligibility Criteria

- 11/15/19 - 1 form, 4 itemgroups, 27 items, 1 language
Itemgroups: Administrative, Eligibility Question, Inclusion Criteria, Exclusion Criteria
Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders

Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597 - Screening - Medical Conditions; Alcohol Intake; Drug and Alcohol Screen; Serology (HIV Screen); Electronically Transferred Lab Data

- 11/11/19 - 1 form, 5 itemgroups, 23 items, 1 language
Itemgroups: Medical Conditions, Alcohol Intake, Drug and Alcohol Sreen, Serology - HIV Screen, Electronically Transferred Laboratory Data
Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders

Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597 - Screening - Administrative; Demography; Vital Signs; 12-Lead ECG; Summary Holter

- 11/7/19 - 1 form, 6 itemgroups, 31 items, 1 language
Itemgroups: Administrative, Demography, Vital Signs, Vital Signs, 12-Lead ECG, Summary Holter
Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders

Eligibility Sleep Disorder NCT02002533

- 7/8/19 - 1 form, 2 itemgroups, 19 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Brief Behavioral Therapy in Improving Sleep Disorders in Patients With Stage I-III Breast Cancer Undergoing Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT02002533

Eligibility Insomnia NCT01256099

- 1/3/19 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Internet-CBT for Insomnia; ODM derived from: https://clinicaltrials.gov/show/NCT01256099

Eligibility Sleep-disordered Breathing NCT00863421

- 10/29/18 - 1 form, 2 itemgroups, 21 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Sleep Disordered Breathing in Patients With Chronic Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00863421

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