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Completed

NCT Number: NCT01307046

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Essential Hypertension Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MK-0954A

Drug

Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily

Losartan

Drug

Tablet containing losartan potassium (100 mg), once daily

Placebo to MK-0954A

Drug

Placebo tablet to match MK-0954A, once daily

Placebo to losartan 100 mg

Drug

Placebo tablet to match losartan 100 mg, once daily

Placebo to losartan 50 mg

Drug

Placebo tablet to match losartan 50 mg, once daily

Primary outcomes

  1. Change From Baseline in 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 (Day 56 ± 7 days).

  2. Percentage of Participants Who Experienced at Least One Adverse Event (AE)

    Time frame: 8 weeks

Secondary outcomes

  1. Change From Baseline in 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 (Day 56 ± 7 days).

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 2, 2011
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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