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Trial record 40 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

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

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ClinicalTrials.gov Identifier: NCT01302691
Recruitment Status : Completed
First Posted : February 24, 2011
Results First Posted : January 27, 2017
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE February 22, 2011
First Posted Date  ICMJE February 24, 2011
Results First Submitted Date  ICMJE December 5, 2016
Results First Posted Date  ICMJE January 27, 2017
Last Update Posted Date March 15, 2019
Actual Study Start Date  ICMJE January 1, 2011
Actual Primary Completion Date April 1, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2016)
  • Change in Mean Trough Sitting Diastolic Blood Pressure (SiDBP) [ Time Frame: Baseline and Week 8 ]
    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) [ Time Frame: up to 14 days after last dose of study drug (up to 10 weeks) ]
    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 [ Time Frame: up to 14 days after last dose of study drug (up to 10 weeks) ]
    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) [ Time Frame: up to 14 days after last dose of study drug (up to 10 weeks) ]
    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 [ Time Frame: up to 14 days after last dose of study drug (up to 10 weeks) ]
    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 [ Time Frame: up to 8 weeks ]
    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
Original Primary Outcome Measures  ICMJE
 (submitted: February 23, 2011)
Change in mean trough sitting diastolic blood pressure (SiDBP). [ Time Frame: 8 Weeks ]
Change History Complete list of historical versions of study NCT01302691 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2016)
Change in Mean Trough Sitting Systolic Blood Pressure (SiSBP) [ Time Frame: Baseline and Week 8 ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2011)
Change in mean trough sitting systolic blood pressure (SiSBP). [ Time Frame: 8 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MK-0954E Study in Participants With Hypertension (MK-0954E-357)
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E)
    One tablet, containing 50 mg losartan potassium, 12.5 mg hydrochlorothiazide, and 5 mg amlodipine besylate, orally, once daily, for 8 weeks.
  • Drug: Losartan potassium
    One tablet, containing 50 mg losartan potassium, orally, once daily, for 8 weeks.
  • Drug: Amlodipine besylate
    One capsule, containing 5 mg amlodipine besylate, orally, once daily, for 8 weeks.
  • Drug: Placebo to MK-0954E
    One tablet, containing placebo, orally, once daily, for 8 weeks.
  • Drug: Placebo to losartan potassium
    One tablet, containing placebo, orally, once daily, for 8 weeks.
  • Drug: Placebo to amlodipine besylate
    One capsule, containing placebo, orally, once daily, for 8 weeks.
Study Arms  ICMJE
  • Experimental: L50/H12.5/A5
    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.
    Interventions:
    • Drug: losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E)
    • Drug: Placebo to losartan potassium
    • Drug: Placebo to amlodipine besylate
  • Active Comparator: L50 + A5
    Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
    Interventions:
    • Drug: Losartan potassium
    • Drug: Amlodipine besylate
    • Drug: Placebo to MK-0954E
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2012)
327
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2011)
326
Actual Study Completion Date  ICMJE April 1, 2012
Actual Primary Completion Date April 1, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Japan
 
Administrative Information
NCT Number  ICMJE NCT01302691
Other Study ID Numbers  ICMJE 0954E-357
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP