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A Long-term Study of the Safety of MK-0954A in Patients With Essential Hypertension (MK-0954A-351)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01307033
First received: March 1, 2011
Last updated: October 9, 2014
Last verified: October 2014

March 1, 2011
October 9, 2014
March 2011
December 2012   (final data collection date for primary outcome measure)
Percentage of Participants Who Experienced an Adverse Event When Receiving MK-0954A (L100/H12.5) During Study (8-week Double-blind and/or 44-week Open-label Extension) [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
Number of participants experiencing adverse events [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01307033 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8 [ Time Frame: Baseline and Week 8 (End of Double-blind Period) ] [ Designated as safety issue: No ]
    Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings.
  • Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8 [ Time Frame: Baseline and Week 8 (End of Double-blind Period) ] [ Designated as safety issue: No ]
    Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings.
  • Change in trough sitting diastolic blood pressure (SiDBP) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Change in trough sitting systolic blood pressure (SiSBP) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Long-term Study of the Safety of MK-0954A in Patients With Essential Hypertension (MK-0954A-351)
A Phase III, Randomized, Active-comparator Controlled and a Long-term Clinical Trial to Study the Safety of MK-0954A (L100/H12.5 mg) in Japanese Patients With Essential Hypertension Uncontrolled With MK-954H (L50/H12.5 mg) [PREMINENT®]

This study is being conducted to evaluate the safety of MK-0954A (L100/H12.5 mg) in essential hypertension participants who are uncontrolled with MK-954H (L50/H12.5 mg).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: MK-0954A
    Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily
  • Drug: MK-954H
    Tablet containing losartan potassium (50 mg) and hydrochlorothiazide (12.5 mg), once daily
    Other Name: Preminent®
  • Drug: Placebo to MK-0954A
    Placebo tablet to match MK-0954A, once daily
  • Drug: Placebo to MK-954H
    Placebo tablet to match MK-954H, once daily
  • Active Comparator: MK-954H (L50/H12.5)
    One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
    Interventions:
    • Drug: MK-954H
    • Drug: Placebo to MK-0954A
  • Experimental: MK-0954A (L100/H12.5)
    One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension
    Interventions:
    • Drug: MK-0954A
    • Drug: Placebo to MK-954H
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
278
December 2012
December 2012   (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 >=90mmHg and < 110mmHg.
  • Participant has a mean trough SiSBP of >=140mmHg and < 200mmHg.
  • 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 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.
  • 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
 
NCT01307033
0954A-351
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