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MK-0954E Study in Participants With Hypertension (MK-0954E-357)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01302691
First received: February 22, 2011
Last updated: December 5, 2016
Last verified: December 2016
  Purpose
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).

Condition Intervention Phase
Hypertension
Drug: losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E)
Drug: Losartan potassium
Drug: Amlodipine besylate
Drug: Placebo to MK-0954E
Drug: Placebo to losartan potassium
Drug: Placebo to amlodipine besylate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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

  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 327
Study Start Date: January 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E)
One tablet, containing 50 mg losartan potassium, 12.5 mg hydrochlorothiazide, and 5 mg amlodipine besylate, orally, once daily, for 8 weeks.
Drug: Placebo to losartan potassium
One tablet, containing placebo, orally, once daily, for 8 weeks.
Drug: Placebo to amlodipine besylate
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.
Drug: Losartan potassium
One tablet, containing 50 mg losartan potassium, orally, once daily, for 8 weeks.
Drug: Amlodipine besylate
One capsule, containing 5 mg amlodipine besylate, orally, once daily, for 8 weeks.
Drug: Placebo to MK-0954E
One tablet, containing placebo, orally, once daily, for 8 weeks.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302691

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01302691     History of Changes
Other Study ID Numbers: 0954E-357 
Study First Received: February 22, 2011
Results First Received: December 5, 2016
Last Updated: December 5, 2016

Keywords provided by Merck Sharp & Dohme Corp.:
Essential hypertension
Uncontrolled hypertension
Antihypertensive agents
Blood pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Hydrochlorothiazide
Losartan
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on February 20, 2017