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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01307033
First received: March 1, 2011
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Hypertension
 Drug: MK-0954A
Drug: MK-954H
Drug: Placebo to MK-0954A
Drug: Placebo to MK-954H
 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 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®]

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Number of participants experiencing adverse events [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in trough sitting diastolic blood pressure (SiDBP) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Change in trough sitting systolic blood pressure (SiSBP) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]

Enrollment: 278
Study Start Date: March 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MK-954H (L50/H12.5 mg) Arm Drug: MK-954H
Tablet containing losartan potassium (50 mg) and hydrochlorothiazide (12.5 mg), once daily
Other Name: Preminent®
Drug: Placebo to MK-0954A
Placebo tablet to match MK-0954A, once daily
Experimental: MK-0954A (L100/H12.5 mg) Arm Drug: MK-0954A
Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily
Drug: Placebo to MK-954H
Placebo tablet to match MK-954H, once daily

  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 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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01307033     History of Changes
Other Study ID Numbers: MK-0954A-351
Study First Received: March 1, 2011
Last Updated: January 2, 2013
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
Losartan
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013