NCT00209846CompletedPhase 3
A Prospective Randomised Double-Blind Parallel-Group Placebo-Controlled Study of Gaboxadol in Primary Insomnia
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- H. Lundbeck A/S
- Enrollment
- 320
- Locations
- 2
- Primary Endpoint
- Safety
Study Overview
Brief Summary
To evaluate the safety and tolerability of gaboxadol in primary insomnia.
Detailed Description
To obtain long-term safety data in elderly patients with gaboxadol.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 66 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with a diagnosis of primary insomnia
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Safety
Tolerability
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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