Clinical trial NCT01307046: MK-0954A in Japanese Patients With Essential Hypertension Not Adequately Controlled With Losartan (MK-0954A-352)
Official title: A Phase III, Randomized, Active-comparator Controlled Clinical Trial to Study the Efficacy and Safety of MK-0954A in Japanese Patients With Essential Hypertension Uncontrolled With the High Dose of Losartan Potassium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Essential hypertension
Uncontrolled hypertension
Antihypertensive agents
Blood pressure
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2011-03-02
Enrollment: 336
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to evaluate the efficacy of MK-0954A in essential hypertension participants who are not adequately controlled with losartan.


Eligibility criteria: Inclusion criteria:

* Participant has a diagnosis of essential hypertension.
* Participant is not treated with antihypertensive medication and meets protocol-specified blood pressure criteria.
* Participant is treated with single antihypertensive medication, and meets protocol-specified blood pressure criteria.
* Participant is being treated with up to dual oral antihypertensive medications, and will be able to discontinue the prior antihypertensive medication.
* Participant has no clinically meaningful findings to be disqualified from the study at the discretion of the investigator.

Exclusion criteria:

* Regarding hypertension, participant is currently taking \> 2 antihypertensive medications.
* Participant has a history of significant multiple and/or severe allergies to ingredients of Nu-lotan or Preminent and thiazide drug or related drug (i.e., sulfonamide-containing "chlortalidone" medicines)
* Participant is, at the time of signing informed consent, a user of recreational or illicit drugs or a recent history within the last year of drug or alcohol abuse or dependence.
* Participant is pregnant or breastfeeding or expecting to conceive or has a positive pregnancy test at the screening visit.
* Participant is currently participating or has participated in a study with an investigational compound (except losartan at any doses) or device within 30 days of signing informed consent.

Primary outcomes:
measure: Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP)
timeFrame: Baseline and Week 8
measure: Percentage of Participants Who Experienced at Least One Adverse Event (AE)
timeFrame: 8 weeks
Secondary outcomes:
measure: Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP)
timeFrame: Baseline and Week 8
Other outcomes:
Locations:
Study officials:
References:
citation: Rakugi H, Tsuchihashi T, Shimada K, Numaguchi H, Nishida C, Yamaguchi H, Fujimoto G, Azuma K, Shirakawa M, Hanson ME, Fujita KP. Efficacy and safety of losartan 100 mg/hydrochlorothiazide 12.5 mg in Japanese subjects with essential hypertension: two randomized, controlled trials. Hypertens Res. 2014 Dec;37(12):1042-9. doi: 10.1038/hr.2014.114. Epub 2014 Jul 3.