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COSMOS
NCT00347360Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2006
- Primary completion
- Apr 2008
- Countries
- 1
- Sponsor
- GSK
- Modality
- Small Molecules
- Drugs
- carvedilol
- Conditions
- hypertension (HTN)
01
Overview
Phase 3, randomised, double-blind trial of carvedilol in hypertension (HTN) (15 arms), sponsored by GSK. Primary endpoints: Change From Baseline to Week 6 in 24 Hour Mean Diastolic Blood Pressure and Change From Baseline to Week 6 in Trough Diastolic Blood Pressure. Started Jul 2006; status: completed.
02
Design
15 arms- Study design
- RandomizedDouble-blind
Carvedilol 20 mg
Carvedilol CR 20 mg QD
Carvedilol 40 mg
Carvedilol CR 40 mg QD
Carvedilol 80 mg
Carvedilol CR 80 mg QD
Lisinopril 10 mg
Lisinopril 10 mg QD
Lisinopril 20 mg
Lisinopril 20 mg QD
Lisinopril 40 mg
Lisinopril 40 mg QD
9 more in the full profile.
03
Who it enrols
Patients 18 years or older with Stage 1 or 2 hypertension (mean sitting DBP 90-109 mmHg, or 80-109 mmHg for diabetics). Excludes patients with severe hypertension (SBP >= 180 mmHg), secondary hypertension, advanced retinopathy, Type 1 diabetes, uncontrolled Type 2 diabetes (HbA1c >= 9%), severe renal or hepatic disease, CHF NYHA II-IV, or history of stroke/MI within 3 months.
04
Endpoints
Primary
Change From Baseline to Week 6 in 24 Hour Mean Diastolic Blood Pressure
Change From Baseline to Week 6 in Trough Diastolic Blood Pressure
Secondary
Change From Baseline to Week 6 in 24 Hour Mean Systolic Blood Pressure
Change From Baseline to Week 6 in Trough Systolic Blood Pressure
Dose-response Treatment Estimates: Change From Baseline to Week 6 in 24 Hour Mean DBP
Change From Baseline to Week 6 in Trough to Peak Ratios of DBP
Overall Description of Safety in Each Treatment Group
Change From Baseline to Week 6 in Mean SBP and DBP Measured in Morning
Change From Baseline to Week 6 in Mean SBP and DBP Measured in Afternoon
Change From Baseline to Week 6 in Mean SBP and DBP Measured at Night
05
Results
Not all primary endpoints met
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