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

Organon and Co278 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

278

Conditions

Hypertension

Interventions

MK-0954ADRUG

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

MK-954HDRUG

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

Placebo to MK-0954ADRUG

Placebo tablet to match MK-0954A, once daily

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

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.

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

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

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

Data from ClinicalTrials.gov

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