MK-0954E Study in Participants With Hypertension (MK-0954E-357)
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E); Losartan potassium; Amlodipine besylate; Placebo to MK-0954E; Placebo to losartan potassium; Placebo to amlodipine besylate
Intervention description: One tablet, containing 50 mg losartan potassium, 12.5 mg hydrochlorothiazide, and 5 mg amlodipine besylate, orally, once daily, for 8 weeks.; One tablet, containing 50 mg losartan potassium, orally, once daily, for 8 weeks.; One capsule, containing 5 mg amlodipine besylate, orally, once daily, for 8 weeks.; One tablet, containing placebo, orally, once daily, for 8 weeks.; One tablet, containing placebo, orally, once daily, for 8 weeks.; One capsule, containing placebo, orally, once daily, for 8 weeks.
Intervention MeSH terms: Losartan; Amlodipine; Hydrochlorothiazide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 327.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Essential hypertension; Uncontrolled hypertension; Antihypertensive agents; Blood pressure

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.