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MK-0954E Study in Participants With Hypertension (MK-0954E-357)

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E)
Losartan potassium
Amlodipine besylate
Placebo to MK-0954E
Placebo to losartan potassium
Placebo to amlodipine besylate
Sponsored by
Merck Sharp & Dohme LLC
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 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    L50/H12.5/A5

    L50 + A5

    Arm Description

    Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.

    Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.

    Outcomes

    Primary Outcome Measures

    Change in Mean 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 at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.
    Percentage of Participants Who Experience ≥1 Adverse Event (AE)
    An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced at least 1 AE during the 10-week treatment and follow-up period were summarized by study drug received.
    Percentage of Participants Who Experience ≥1 Drug-related AE
    An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 10-week treatment and follow-up period were summarized by study drug received.
    Percentage of Participants Who Experience ≥1 Serious Adverse Event (SAE)
    An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. The percentage of participants who experienced at least 1 SAE during the 10-week treatment and follow-up period were summarized by study drug received.
    Percentage of Participants Who Experience ≥1 Drug-related SAE
    An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Percentage of participants that experienced at least 1 SAE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 10-week treatment and follow-up period were summarized by study drug received
    Percentage of Participants Who Had Study Drug Stopped Due to an AE
    An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug stopped during the 8-week treatment period due to an AE regardless of whether or not they completed the study was summarized by treatment arm

    Secondary Outcome Measures

    Change in Mean 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 at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.

    Full Information

    First Posted
    February 22, 2011
    Last Updated
    February 28, 2019
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01302691
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2011 (Actual)
    Primary Completion Date
    April 1, 2012 (Actual)
    Study Completion Date
    April 1, 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).

    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
    327 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    L50/H12.5/A5
    Arm Type
    Experimental
    Arm Description
    Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
    Arm Title
    L50 + A5
    Arm Type
    Active Comparator
    Arm Description
    Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E)
    Intervention Description
    One tablet, containing 50 mg losartan potassium, 12.5 mg hydrochlorothiazide, and 5 mg amlodipine besylate, orally, once daily, for 8 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Losartan potassium
    Intervention Description
    One tablet, containing 50 mg losartan potassium, orally, once daily, for 8 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Amlodipine besylate
    Intervention Description
    One capsule, containing 5 mg amlodipine besylate, orally, once daily, for 8 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to MK-0954E
    Intervention Description
    One tablet, containing placebo, orally, once daily, for 8 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to losartan potassium
    Intervention Description
    One tablet, containing placebo, orally, once daily, for 8 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to amlodipine besylate
    Intervention Description
    One capsule, containing placebo, orally, once daily, for 8 weeks.
    Primary Outcome Measure Information:
    Title
    Change in Mean 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 at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.
    Time Frame
    Baseline and Week 8
    Title
    Percentage of Participants Who Experience ≥1 Adverse Event (AE)
    Description
    An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced at least 1 AE during the 10-week treatment and follow-up period were summarized by study drug received.
    Time Frame
    up to 14 days after last dose of study drug (up to 10 weeks)
    Title
    Percentage of Participants Who Experience ≥1 Drug-related AE
    Description
    An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 10-week treatment and follow-up period were summarized by study drug received.
    Time Frame
    up to 14 days after last dose of study drug (up to 10 weeks)
    Title
    Percentage of Participants Who Experience ≥1 Serious Adverse Event (SAE)
    Description
    An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. The percentage of participants who experienced at least 1 SAE during the 10-week treatment and follow-up period were summarized by study drug received.
    Time Frame
    up to 14 days after last dose of study drug (up to 10 weeks)
    Title
    Percentage of Participants Who Experience ≥1 Drug-related SAE
    Description
    An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Percentage of participants that experienced at least 1 SAE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 10-week treatment and follow-up period were summarized by study drug received
    Time Frame
    up to 14 days after last dose of study drug (up to 10 weeks)
    Title
    Percentage of Participants Who Had Study Drug Stopped Due to an AE
    Description
    An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug stopped during the 8-week treatment period due to an AE regardless of whether or not they completed the study was summarized by treatment arm
    Time Frame
    up to 8 weeks
    Secondary Outcome Measure Information:
    Title
    Change in Mean 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 at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.
    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 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    25271811
    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.
    Results Reference
    result
    PubMed Identifier
    25716649
    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.
    Results Reference
    result

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    MK-0954E Study in Participants With Hypertension (MK-0954E-357)

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