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MK-0954A in Japanese Patients With Essential Hypertension Not Adequately Controlled With Losartan (MK-0954A-352)

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK-0954A
Losartan
Placebo to MK-0954A
Placebo to losartan 100 mg
Placebo to losartan 50 mg
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Essential hypertension, Uncontrolled hypertension, Antihypertensive agents, Blood pressure

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    MK-0954A

    Losartan

    Arm Description

    Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.

    Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP)
    Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).
    Percentage of Participants Who Experienced at Least One Adverse Event (AE)

    Secondary Outcome Measures

    Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP)
    Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).

    Full Information

    First Posted
    March 1, 2011
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01307046
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    March 29, 2011 (Actual)
    Primary Completion Date
    February 7, 2012 (Actual)
    Study Completion Date
    February 7, 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension
    Keywords
    Essential hypertension, Uncontrolled hypertension, Antihypertensive agents, Blood pressure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    336 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MK-0954A
    Arm Type
    Experimental
    Arm Description
    Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
    Arm Title
    Losartan
    Arm Type
    Active Comparator
    Arm Description
    Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    MK-0954A
    Intervention Description
    Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Losartan
    Intervention Description
    Tablet containing losartan potassium (100 mg), once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to MK-0954A
    Intervention Description
    Placebo tablet to match MK-0954A, once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to losartan 100 mg
    Intervention Description
    Placebo tablet to match losartan 100 mg, once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to losartan 50 mg
    Intervention Description
    Placebo tablet to match losartan 50 mg, once daily
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP)
    Description
    Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).
    Time Frame
    Baseline and Week 8
    Title
    Percentage of Participants Who Experienced at Least One Adverse Event (AE)
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP)
    Description
    Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).
    Time Frame
    Baseline and Week 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    24990091
    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. Erratum In: Hypertens Res. 2014 Dec;37(12):1088.
    Results Reference
    result

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    MK-0954A in Japanese Patients With Essential Hypertension Not Adequately Controlled With Losartan (MK-0954A-352)

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