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

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®]

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 Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: MK-954H; Drug: Placebo to MK-0954A; Drug: MK-0954A; Drug: Placebo to MK-954H

• Study Type: Interventional
• Enrollment (Actual): 278
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	Drug: MK-954H; Tablet containing losartan potassium (50 mg) and hydrochlorothiazide (12.5 mg), once daily; Other Names: Preminent®; Drug: Placebo to MK-0954A; Placebo tablet to match MK-0954A, once daily
Experimental: 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	Drug: MK-0954A; Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily; Drug: Placebo to MK-954H; Placebo tablet to match MK-954H, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	Up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 8 (End of Double-blind Period)
Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) 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.	Baseline and Week 8 (End of Double-blind Period)

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• Rakugi H, Tsuchihashi T, Shimada K, Numaguchi H, Nishida C, Yamaguchi H, Fujimoto G, Azuma K, Shirakawa M, Hanson ME, Fujita KP. Efficacy and safety of losartan 100 mg/hydrochlorothiazide 12.5 mg in Japanese subjects with essential hypertension: two randomized, controlled trials. Hypertens Res. 2014 Dec;37(12):1042-9. doi: 10.1038/hr.2014.114. Epub 2014 Jul 3. Erratum In: Hypertens Res. 2014 Dec;37(12):1088.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2011
• Primary Completion (Actual): December 4, 2012
• Study Completion (Actual): December 4, 2012

Study Registration Dates

• First Submitted: March 1, 2011
• First Submitted That Met QC Criteria: March 1, 2011
• First Posted (Estimated): March 2, 2011

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Blood pressure; Essential hypertension; Uncontrolled hypertension; Antihypertensive agents
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Losartan
• Other Study ID Numbers: 0954A-351

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php