Clinical trial NCT01302691: MK-0954E Study in Participants With Hypertension (MK-0954E-357)
Official title: A Phase III, Randomized, Active-Comparator Controlled Clinical Trial to Study the Efficacy and Safety of MK-0954E in Japanese Patients With Essential Hypertension Uncontrolled With Losartan and Amlodipine Co-administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Essential hypertension
Uncontrolled hypertension
Antihypertensive agents
Blood pressure
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-02-24
Enrollment: 327
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 done to evaluate the efficacy, safety, and tolerability of losartan potassium 50 mg (L50) + hydrochlorothiazide 12.5 mg (H12.5) + amlodipine besylate 5 mg (A5) (MK-0954E). The primary hypothesis is that L50/H12.5/A5 is more effective in lowering mean trough sitting diastolic blood pressure (SiDBP) after 8 weeks of treatment compared to L50+A5 in Japanese participants with essential hypertension who are not adequately controlled following an 8-week treatment with filter period study drug (L50+A5).


Eligibility criteria: Inclusion criteria

* Participant has a diagnosis of essential hypertension.
* Participant is being treated with single or dual treatment for hypertension and will be able to discontinue the prior antihypertensive medication.
* Participant has a mean trough SiDBP of ≥ 90 mmHg and \< 110 mmHg.
* Participant has a mean trough SiSBP of ≥ 140 mmHg and \< 200 mmHg.
* 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, amlodipine or dihydropyridine drug, 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 (Visit 1).
* 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: Change in Mean Trough Sitting Diastolic Blood Pressure (SiDBP)
timeFrame: Baseline and Week 8
measure: Percentage of Participants Who Experience ≥1 Adverse Event (AE)
timeFrame: up to 14 days after last dose of study drug (up to 10 weeks)
measure: Percentage of Participants Who Experience ≥1 Drug-related AE
timeFrame: up to 14 days after last dose of study drug (up to 10 weeks)
measure: Percentage of Participants Who Experience ≥1 Serious Adverse Event (SAE)
timeFrame: up to 14 days after last dose of study drug (up to 10 weeks)
measure: Percentage of Participants Who Experience ≥1 Drug-related SAE
timeFrame: up to 14 days after last dose of study drug (up to 10 weeks)
measure: Percentage of Participants Who Had Study Drug Stopped Due to an AE
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Change in Mean Trough Sitting Systolic Blood Pressure (SiSBP)
timeFrame: Baseline and Week 8
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Rakugi H, Tsuchihashi T, Shimada K, Numaguchi H, Nishida C, Yamaguchi H, Shirakawa M, Azuma K, Fujita KP. Efficacy and safety of fixed-dose losartan/hydrochlorothiazide/amlodipine combination versus losartan/hydrochlorothiazide combination in Japanese patients with essential hypertension. Clin Exp Hypertens. 2015;37(3):260-6. doi: 10.3109/10641963.2014.954712. Epub 2014 Oct 1.
citation: Rakugi H, Tsuchihashi T, Shimada K, Numaguchi H, Nishida C, Yamaguchi H, Shirakawa M, Azuma K, Fujita KP. Add-on effect of hydrochlorothiazide 12.5 mg in Japanese subjects with essential hypertension uncontrolled with losartan 50 mg and amlodipine 5 mg. Hypertens Res. 2015 May;38(5):329-35. doi: 10.1038/hr.2015.3. Epub 2015 Feb 26.