MK-0954E Phase III Long-Term Study in Participants With Hypertension (MK-0954E-356)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01299376
First received: February 16, 2011
Last updated: October 6, 2014
Last verified: October 2014

February 16, 2011
October 6, 2014
January 2011
November 2011   (final data collection date for primary outcome measure)
Change in mean trough sitting diastolic blood pressure [SiDBP]. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01299376 on ClinicalTrials.gov Archive Site
Change in mean trough sitting systolic blood pressure [SiSBP]. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
MK-0954E Phase III Long-Term Study in Participants With Hypertension (MK-0954E-356)
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 MK-954H (L50/H12.5 mg) [PREMINENT®] and an Open-label, Long-term Clinical Trial to Study the Safety of MK-0954E

This study has two parts. In the first part, losartan potassium (+) hydrochlorothiazide (+) amlodipine besylate (MK-0954E [losartan/HCTZ/amlodipine]) will be evaluated for efficacy, safety and tolerability and to determine if losartan/HCTZ/amlodipine is better than losartan potassium (+) hydrochlorothiazide (MK-0954H [losartan/HCTZ]) for participants. In the second part, the safety and tolerability of long-term use of open-label losartan/HCTZ/amlodipine in participants with hypertension will be evaluated.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 up to 52 weeks.
  • Drug: losartan potassium (+) hydrochlorothiazide
    One tablet containing 50 mg losartan potassium and 12.5 mg hydrochlorothiazide, 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 (+) hydrochlorothiazide
    One tablet containing placebo, orally, once daily, for 8 weeks.
  • Experimental: Losartan/HCTZ/amlodipine Treatment Arm
    Interventions:
    • Drug: losartan potassium (+) hydrochlorothiazide (+) amlodipine besylate (MK-0954E)
    • Drug: Placebo to losartan potassium (+) hydrochlorothiazide
  • Active Comparator: Losartan/HCTZ Treatment Arm
    Interventions:
    • Drug: losartan potassium (+) hydrochlorothiazide
    • Drug: Placebo to MK-0954E
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
268
September 2012
November 2011   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Participant has a diagnosis of essential hypertension.
  • Participant is being treated with a single, or dual combination 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.
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01299376
0954E-356
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
October 2014

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