Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the efficacy, safety and tolerability of a combination of Vestipitant and Paroxetine in patients with Social Anxiety Disorder (SAD)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vestipitant/paroxetine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in score on a Social Anxiety Disorder rating scale following 12 weeks of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in score on a number of rating scales following 12 weeks of treatment assessing symptomatic, behavioural and functional parameters which together provide a more complete description of the disorder. |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Hilleroed | 3400 | Denmark | |||
| GSK Investigational Site |
Not provided
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| NKP103401 | Clinical Study Report | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C534550 | vestipitant |
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hvidovre |
| 2650 |
| Denmark |
| GSK Investigational Site | Koebenhavn K | 1256 | Denmark |
| GSK Investigational Site | Koebenhavn OE | 2100 | Denmark |
| GSK Investigational Site | Risskov | 8240 | Denmark |
| GSK Investigational Site | Skanderborg | 8660 | Denmark |
| GSK Investigational Site | Soroe | 4180 | Denmark |
| GSK Investigational Site | Hüttenberg | Hesse | 35625 | Germany |
| GSK Investigational Site | Achim | Lower Saxony | 28832 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10629 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13053 | Germany |
| GSK Investigational Site | Bergen | N-5068 | Norway |
| GSK Investigational Site | Hamar | N-2317 | Norway |
| GSK Investigational Site | Oslo | 0364 | Norway |
| GSK Investigational Site | Sandvika | 1338 | Norway |
| GSK Investigational Site | Bloemfontein | South Africa |
| GSK Investigational Site | Tygerberg | 7505 | South Africa |
For additional information about this study please refer to the GSK Clinical Study Register |
| NKP103401 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKP103401 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKP103401 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKP103401 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKP103401 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKP103401 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |