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

Hypertension Clinical Trial

Official title:

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®]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307033
• Other study ID #: 0954A-351
• Status: Completed
• Phase: Phase 3
• Start date: March 29, 2011
• Est. completion date: December 4, 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 safety of MK-0954A (L100/H12.5 mg) in essential hypertension participants who are uncontrolled with MK-954H (L50/H12.5 mg).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: December 4, 2012
• Est. primary completion date: December 4, 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 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.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• MK-0954A
Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily
• MK-954H
Tablet containing losartan potassium (50 mg) and hydrochlorothiazide (12.5 mg), once daily
• Placebo to MK-0954A
Placebo tablet to match MK-0954A, once daily
• Placebo to MK-954H
Placebo tablet to match MK-954H, 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	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	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)
Secondary	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)