MK-0954A in Japanese Patients With Essential Hypertension Not Adequately Controlled With Losartan (MK-0954A-352)

NCT01307046 | Completed Phase 3 Results

• 1 other identifier: 0954A-352
• Study Type: interventional
• Target: 336
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is being conducted to evaluate the efficacy of MK-0954A in essential hypertension participants who are not adequately controlled with losartan.

Conditions

Hypertension

Keywords

Essential hypertension; Uncontrolled hypertension; Antihypertensive agents; Blood pressure

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP)

  Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).

  Baseline and Week 8

• Percentage of Participants Who Experienced at Least One Adverse Event (AE)

  8 weeks

Secondary Outcomes (1)

• Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP)

  Baseline and Week 8

Study Arms (2)

MK-0954A

EXPERIMENTAL

Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.

Drug: MK-0954A; Drug: Placebo to losartan 100 mg; Drug: Placebo to losartan 50 mg

Losartan

ACTIVE COMPARATOR

Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.

Drug: Losartan; Drug: Placebo to MK-0954A; Drug: Placebo to losartan 50 mg

Interventions

MK-0954A DRUG

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

MK-0954A

Losartan DRUG

Tablet containing losartan potassium (100 mg), once daily

Losartan

Placebo to MK-0954A DRUG

Placebo tablet to match MK-0954A, once daily

Losartan

Placebo to losartan 100 mg DRUG

Placebo tablet to match losartan 100 mg, once daily

MK-0954A

Placebo to losartan 50 mg DRUG

Placebo tablet to match losartan 50 mg, once daily

Losartan; MK-0954A

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has a diagnosis of essential hypertension.
• Participant is not treated with antihypertensive medication and meets protocol-specified blood pressure criteria.
• Participant is treated with single antihypertensive medication, and meets protocol-specified blood pressure criteria.
• Participant is being treated with up to dual oral antihypertensive medications, and will be able to discontinue the prior antihypertensive medication.
• Participant has no clinically meaningful findings to be disqualified from the study at the discretion of the investigator.

You may not qualify if:

• Regarding hypertension, 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 a recent history within the last year of drug or alcohol abuse or dependence.
• Participant is pregnant or breastfeeding or expecting to conceive or has a positive pregnancy test at the screening visit.
• Participant is currently participating or has participated in a study with an investigational compound (except losartan at any doses) or device within 30 days of signing informed consent.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 24990091 RESULT

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Interventions

Losartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merch Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2011
• First Posted: March 2, 2011
• Study Start: March 29, 2011
• Primary Completion: February 7, 2012
• Study Completion: February 7, 2012
• Last Updated: May 17, 2024
• Results First Posted: March 22, 2013

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share