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

Hypertension Clinical Trial

Official title:

A Phase III, Randomized, Active-comparator Controlled Clinical Trial to Study the Efficacy and Safety of MK-0954A in Japanese Patients With Essential Hypertension Uncontrolled With the High Dose of Losartan Potassium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307046
• Other study ID #: 0954A-352
• Status: Completed
• Phase: Phase 3
• Start date: March 29, 2011
• Est. completion date: February 7, 2012

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: February 7, 2012
• Est. primary completion date: February 7, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• MK-0954A
Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily
• Losartan
Tablet containing losartan potassium (100 mg), once daily
• Placebo to MK-0954A
Placebo tablet to match MK-0954A, once daily
• Placebo to losartan 100 mg
Placebo tablet to match losartan 100 mg, once daily
• Placebo to losartan 50 mg
Placebo tablet to match losartan 50 mg, once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & 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 rando — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percentage of Participants Who Experienced at Least One Adverse Event (AE)		8 weeks
Secondary	Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP)	Sitting systolic 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