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MK-0954A in Japanese Patients With Essential Hypertension Not Adequately Controlled With Losartan (MK-0954A-352)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01307046
First received: March 1, 2011
Last updated: February 19, 2013
Last verified: February 2013
History of Changes
  Purpose

This study is being conducted to evaluate the efficacy of MK-0954A in essential hypertension participants who are not adequately controlled with losartan.


Condition Intervention Phase
Hypertension
 Drug: MK-0954A
Drug: Losartan
Drug: Placebo to MK-0954A
Drug: Placebo to losartan 100 mg
Drug: Placebo to losartan 50 mg
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Active-comparator Controlled Clinical Trial to Study the Efficacy and Safety of MK-0954A in Japanese Patients With Essential Hypertension Uncontrolled With the High Dose of Losartan Potassium

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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 (Day 56 ± 7 days).

  • Percentage of Participants Who Experienced at Least One Adverse Event (AE) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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 (Day 56 ± 7 days).


Enrollment: 336
Study Start Date: March 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-0954A
Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
 Drug: MK-0954A
Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily
Drug: Placebo to losartan 100 mg
Placebo tablet to match losartan 100 mg, once daily
Drug: Placebo to losartan 50 mg
Placebo tablet to match losartan 50 mg, once daily
Active Comparator: Losartan
Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
 Drug: Losartan
Tablet containing losartan potassium (100 mg), once daily
Drug: Placebo to MK-0954A
Placebo tablet to match MK-0954A, once daily
Drug: Placebo to losartan 50 mg
Placebo tablet to match losartan 50 mg, once daily

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Participant has a diagnosis of essential hypertension.
  • Participant is not treated with antihypertensive medication and meets protocol-specified blood pressure criteria.
  • Participant is treated with single antihypertensive medication, and meets protocol-specified blood pressure criteria.
  • Participant is being treated with up to dual oral antihypertensive medications, and will be able to discontinue the prior antihypertensive medication.
  • Participant has no clinically meaningful findings to be disqualified from the study at the discretion of the investigator.

Exclusion criteria:

  • Regarding hypertension, 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 a recent history within the last year of drug or alcohol abuse or dependence.
  • Participant is pregnant or breastfeeding or expecting to conceive or has a positive pregnancy test at the screening visit.
  • Participant is currently participating or has participated in a study with an investigational compound (except losartan at any doses) or device within 30 days of signing informed consent.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01307046     History of Changes
Other Study ID Numbers: MK-0954A-352
Study First Received: March 1, 2011
Results First Received: January 2, 2013
Last Updated: February 19, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Merck:
Essential hypertension
Uncontrolled hypertension
Antihypertensive agents
Blood pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Losartan
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013