Back to resultsA Long-term Study of the Safety of MK-0954A in Patients With Essential Hypertension (MK-0954A-351)
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK-0954A
MK-954H
Placebo to MK-0954A
Placebo to MK-954H
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Essential hypertension, Uncontrolled hypertension, Antihypertensive agents, Blood pressure
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
MK-954H (L50/H12.5)
MK-0954A (L100/H12.5)
Arm 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)
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
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01307033
Brief Title
A Long-term Study of the Safety of MK-0954A in Patients With Essential Hypertension (MK-0954A-351)
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®]
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 29, 2011 (Actual)
Primary Completion Date
December 4, 2012 (Actual)
Study Completion Date
December 4, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Essential hypertension, Uncontrolled hypertension, Antihypertensive agents, Blood pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
278 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MK-954H (L50/H12.5)
Arm Type
Active Comparator
Arm 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)
Arm Title
MK-0954A (L100/H12.5)
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
MK-0954A
Intervention Description
Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily
Intervention Type
Drug
Intervention Name(s)
MK-954H
Other Intervention Name(s)
Preminent®
Intervention Description
Tablet containing losartan potassium (50 mg) and hydrochlorothiazide (12.5 mg), once daily
Intervention Type
Drug
Intervention Name(s)
Placebo to MK-0954A
Intervention Description
Placebo tablet to match MK-0954A, once daily
Intervention Type
Drug
Intervention Name(s)
Placebo to MK-954H
Intervention Description
Placebo tablet to match MK-954H, once daily
Primary Outcome Measure Information:
Title
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)
Time Frame
Up to 52 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8
Description
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.
Time Frame
Baseline and Week 8 (End of Double-blind Period)
Title
Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8
Description
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.
Time Frame
Baseline and Week 8 (End of Double-blind Period)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
24990091
Citation
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.
Results Reference
result
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A Long-term Study of the Safety of MK-0954A in Patients With Essential Hypertension (MK-0954A-351)
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