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GSK233705B in COPD
NCT00453479Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2007
- Primary completion
- Oct 2007
- Countries
- 1
- Sponsor
- GSK
- Modality
- Small Molecules
- Drugs
- darotropium bromide
- Conditions
- chronic obstructive pulmonary disease (COPD)
01
Overview
Phase 2, randomised, double-blind trial of darotropium bromide in chronic obstructive pulmonary disease (COPD) (3 arms), sponsored by GSK. Primary endpoints: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) up to 45 days, Summary of Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 7 and 7 more. Started Mar 2007; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
GSK233705B Cohort 1
GSK233705B Low Dose
GSK233705B Cohort 2
GSK233705B High Dose
Placebo
Placebo Comparator
03
Who it enrols
Patients with COPD, aged 40-75, current or ex-smokers, with FEV1 40-80% predicted and FEV1/FVC < 0.7.
04
Endpoints
Primary
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Summary of Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Summary of Mean Heart Rate
Number of Participants With Abnormal 12-lead ECG Findings
Maximum Value and Weighted Mean of ECG Parameters (QTcF and QTcB)
Secondary
Plasma Concentrations and Derived PK Parameters of GSK233705
Urine Concentrations and Derived PK Parameters of GSK233705
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