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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01302691
First received: February 22, 2011
Last updated: December 5, 2016
Last verified: December 2016

February 22, 2011
December 5, 2016
January 2011
April 2012   (Final data collection date for primary outcome measure)
  • 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
Change in mean trough sitting diastolic blood pressure (SiDBP). [ Time Frame: 8 Weeks ]
Complete list of historical versions of study NCT01302691 on ClinicalTrials.gov Archive Site
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.
Change in mean trough sitting systolic blood pressure (SiSBP). [ Time Frame: 8 Weeks ]
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Not Provided
 
MK-0954E Study in Participants With Hypertension (MK-0954E-357)
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
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • 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.
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
327
April 2012
April 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Japan
 
NCT01302691
0954E-357
No
Not Provided
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
December 2016

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