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

Organon

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: MK-0954A; Drug: Placebo to MK-954H; Drug: Placebo to MK-0954A; Drug: MK-954H

Study type: Interventional

Funder types: Industry

Identifiers

NCT01307033

0954A-351

Details and patient eligibility

About

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).

Enrollment: 278 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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278 participants in 2 patient groups

MK-954H (L50/H12.5)

Active Comparator group

Description:

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)

Treatment:

Drug: MK-954H

Drug: Placebo to MK-0954A

MK-0954A (L100/H12.5)

Experimental group

Description:

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

Treatment:

Drug: Placebo to MK-954H

Drug: MK-0954A