- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01302691
MK-0954E Study in Participants With Hypertension (MK-0954E-357)
February 28, 2019 updated by: Merck Sharp & Dohme LLC
A Phase III, Randomized, Active-Comparator Controlled Clinical Trial to Study the Efficacy and Safety of MK-0954E in Japanese Patients With Essential Hypertension Uncontrolled With Losartan and Amlodipine Co-administration
This study is being done to evaluate the efficacy, safety, and tolerability of losartan potassium 50 mg (L50) + hydrochlorothiazide 12.5 mg (H12.5)
+ amlodipine besylate 5 mg (A5) (MK-0954E).
The primary hypothesis is that L50/H12.5/A5 is more effective in lowering mean trough sitting diastolic blood pressure (SiDBP) after 8 weeks of treatment compared to L50+A5 in Japanese participants with essential hypertension who are not adequately controlled following an 8-week treatment with filter period study drug (L50+A5).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
327
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria
- Participant has a diagnosis of essential hypertension.
- Participant is being treated with single or dual treatment for hypertension and will be able to discontinue the prior antihypertensive medication.
- Participant has a mean trough SiDBP of ≥ 90 mmHg and < 110 mmHg.
- Participant has a mean trough SiSBP of ≥ 140 mmHg and < 200 mmHg.
- 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, amlodipine or dihydropyridine drug, 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 (Visit 1).
- 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: L50/H12.5/A5
Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
|
One tablet, containing 50 mg losartan potassium, 12.5 mg hydrochlorothiazide, and 5 mg amlodipine besylate, orally, once daily, for 8 weeks.
One tablet, containing placebo, orally, once daily, for 8 weeks.
One capsule, containing placebo, orally, once daily, for 8 weeks.
|
Active Comparator: L50 + A5
Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
|
One tablet, containing 50 mg losartan potassium, orally, once daily, for 8 weeks.
One capsule, containing 5 mg amlodipine besylate, orally, once daily, for 8 weeks.
One tablet, containing placebo, orally, once daily, for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mean Trough Sitting Diastolic Blood Pressure (SiDBP)
Time Frame: Baseline and Week 8
|
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 at Week 8.
The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.
|
Baseline and Week 8
|
Percentage of Participants Who Experience ≥1 Adverse Event (AE)
Time Frame: up to 14 days after last dose of study drug (up to 10 weeks)
|
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE.
The percentage of participants who experienced at least 1 AE during the 10-week treatment and follow-up period were summarized by study drug received.
|
up to 14 days after last dose of study drug (up to 10 weeks)
|
Percentage of Participants Who Experience ≥1 Drug-related AE
Time Frame: up to 14 days after last dose of study drug (up to 10 weeks)
|
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE.
Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 10-week treatment and follow-up period were summarized by study drug received.
|
up to 14 days after last dose of study drug (up to 10 weeks)
|
Percentage of Participants Who Experience ≥1 Serious Adverse Event (SAE)
Time Frame: up to 14 days after last dose of study drug (up to 10 weeks)
|
An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.
The percentage of participants who experienced at least 1 SAE during the 10-week treatment and follow-up period were summarized by study drug received.
|
up to 14 days after last dose of study drug (up to 10 weeks)
|
Percentage of Participants Who Experience ≥1 Drug-related SAE
Time Frame: up to 14 days after last dose of study drug (up to 10 weeks)
|
An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.
Percentage of participants that experienced at least 1 SAE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 10-week treatment and follow-up period were summarized by study drug received
|
up to 14 days after last dose of study drug (up to 10 weeks)
|
Percentage of Participants Who Had Study Drug Stopped Due to an AE
Time Frame: up to 8 weeks
|
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE.
The percentage of participants who had study drug stopped during the 8-week treatment period due to an AE regardless of whether or not they completed the study was summarized by treatment arm
|
up to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mean Trough Sitting Systolic Blood Pressure (SiSBP)
Time Frame: Baseline and Week 8
|
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 at Week 8.
The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.
|
Baseline and Week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Rakugi H, Tsuchihashi T, Shimada K, Numaguchi H, Nishida C, Yamaguchi H, Shirakawa M, Azuma K, Fujita KP. Efficacy and safety of fixed-dose losartan/hydrochlorothiazide/amlodipine combination versus losartan/hydrochlorothiazide combination in Japanese patients with essential hypertension. Clin Exp Hypertens. 2015;37(3):260-6. doi: 10.3109/10641963.2014.954712. Epub 2014 Oct 1.
- Rakugi H, Tsuchihashi T, Shimada K, Numaguchi H, Nishida C, Yamaguchi H, Shirakawa M, Azuma K, Fujita KP. Add-on effect of hydrochlorothiazide 12.5 mg in Japanese subjects with essential hypertension uncontrolled with losartan 50 mg and amlodipine 5 mg. Hypertens Res. 2015 May;38(5):329-35. doi: 10.1038/hr.2015.3. Epub 2015 Feb 26.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2011
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
February 22, 2011
First Submitted That Met QC Criteria
February 23, 2011
First Posted (Estimate)
February 24, 2011
Study Record Updates
Last Update Posted (Actual)
March 15, 2019
Last Update Submitted That Met QC Criteria
February 28, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Essential Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Sodium Chloride Symporter Inhibitors
- Amlodipine
- Losartan
- Hydrochlorothiazide
Other Study ID Numbers
- 0954E-357
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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