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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
ClinicalTrials.gov Identifier:
NCT01302691
First received: February 22, 2011
Last updated: April 26, 2012
Last verified: April 2012
History of Changes
  Purpose

This study is being done to evaluate the efficacy, safety, and tolerability of losartan potassium (+) hydrochlorothiazide (+) amlodipine besylate (MK-0954E [losartan/HCTZ/amlodipine]) and to find out whether losartan/HCTZ/amlodipine is better than the combination therapy of losartan potassium (+) amlodipine besylate (losartan/amlodipine) in participants with hypertension.


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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change in mean trough sitting diastolic blood pressure (SiDBP). [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in mean trough sitting systolic blood pressure (SiSBP). [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

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: Losartan/HCTZ/amlodipine Treatment Arm 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: Losartan/amlodipine Treatment Arm 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
Genders Eligible for Study:   Both
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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01302691     History of Changes
Other Study ID Numbers: MK-0954E-357
Study First Received: February 22, 2011
Last Updated: April 26, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Merck:
Essential hypertension
Uncontrolled hypertension
Antihypertensive agents
Blood pressure

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

ClinicalTrials.gov processed this record on May 22, 2013