Clinical trial NCT01307033: A Long-term Study of the Safety of MK-0954A in Patients With Essential Hypertension (MK-0954A-351)
Official title: A Phase III, Randomized, Active-comparator Controlled and a Long-term Clinical Trial to Study the Safety of MK-0954A (L100/H12.5 mg) in Japanese Patients With Essential Hypertension Uncontrolled With MK-954H (L50/H12.5 mg) [PREMINENT®]
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: 278
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 safety of MK-0954A (L100/H12.5 mg) in essential hypertension participants who are uncontrolled with MK-954H (L50/H12.5 mg).


Eligibility criteria: Inclusion criteria:

* Participant has a diagnosis of essential hypertension.
* Participant is being treated with a single, or dual combination treatment for hypertension and will be able to discontinue the prior antihypertensive medication.
* Participant has a mean trough SiDBP of \>=90mmHg and \< 110mmHg.
* Participant has a mean trough SiSBP of \>=140mmHg and \< 200mmHg.
* Participant has no clinically significant abnormality at screening visit.

Exclusion criteria:

* 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 has had a recent history within the last year of drug or alcohol abuse or dependence.
* Participant is pregnant or breastfeeding, or expecting to conceive or the pregnancy test is positive at screening visit.
* Participant is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.

Primary outcomes:
measure: Percentage of Participants Who Experienced an Adverse Event When Receiving MK-0954A (L100/H12.5) During Study (8-week Double-blind and/or 44-week Open-label Extension)
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8
timeFrame: Baseline and Week 8 (End of Double-blind Period)
measure: Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8
timeFrame: Baseline and Week 8 (End of Double-blind Period)
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.