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MK-0954A Safety in Japanese Patients With Essential Hypertension
NCT01307033Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2011
- Primary completion
- Dec 2012
- Sponsor
- Organon & Co.
- Modality
- Small Molecules
- Conditions
- essential hypertension
01
Overview
Phase 3, randomised, double-blind trial of losartan and hydrochlorothiazide in essential hypertension (2 arms), sponsored by Organon & Co. Primary endpoint: Percentage of Participants Who Experienced an Adverse Event at 52 weeks. Started Mar 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
MK-954H (L50/H12.5)
Losartan 50 mg / HCTZ 12.5 mg daily for 8 weeks, then switch to MK-0954A
MK-0954A (L100/H12.5)
Losartan 100 mg / HCTZ 12.5 mg daily for 8 weeks, then continue MK-0954A
03
Who it enrols
Japanese patients with essential hypertension, currently treated with single or dual antihypertensive medication, with trough SiDBP 90-110 mmHg and SiSBP 140-200 mmHg.
04
Endpoints
Primary
Percentage of Participants Who Experienced an Adverse Event
Secondary
Change From Baseline in Trough Sitting Diastolic Blood Pressure
Change From Baseline in Trough Sitting Systolic Blood Pressure
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