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Completed

NCT Number: NCT01307033

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

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).

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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 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.

Treatment and study plan

MK-0954A

Drug

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

MK-954H

Drug

Tablet containing losartan potassium (50 mg) and hydrochlorothiazide (12.5 mg), once daily

Other names: Preminent®

Placebo to MK-0954A

Drug

Placebo tablet to match MK-0954A, once daily

Placebo to MK-954H

Drug

Placebo tablet to match MK-954H, once daily

Primary outcomes

  1. 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

Secondary outcomes

  1. Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8

    Time frame: Baseline and Week 8 (End of Double-blind Period)

    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.

  2. Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8

    Time frame: Baseline and Week 8 (End of Double-blind Period)

    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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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®]

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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