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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-29

Study Completion Date

2012-12-04

Brief Summary

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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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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

MK-954H

Intervention Type DRUG

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

Placebo to MK-0954A

Intervention Type DRUG

Placebo tablet to match MK-0954A, once daily

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

Group Type EXPERIMENTAL

MK-0954A

Intervention Type DRUG

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

Placebo to MK-954H

Intervention Type DRUG

Placebo tablet to match MK-954H, once daily

Interventions

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MK-0954A

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

Intervention Type DRUG

MK-954H

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

Intervention Type DRUG

Placebo to MK-0954A

Placebo tablet to match MK-0954A, once daily

Intervention Type DRUG

Placebo to MK-954H

Placebo tablet to match MK-954H, once daily

Intervention Type DRUG

Other Intervention Names

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Preminent®

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No