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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01307033
First received: March 1, 2011
Last updated: October 9, 2014
Last verified: October 2014
  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 (Subject, Investigator)
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:


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

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) [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8 [ Time Frame: Baseline and Week 8 (End of Double-blind Period) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 8 (End of Double-blind Period) ] [ Designated as safety issue: No ]
    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.


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)
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)
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)
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
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
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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01307033     History of Changes
Other Study ID Numbers: 0954A-351
Study First Received: March 1, 2011
Results First Received: November 14, 2013
Last Updated: October 9, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

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

ClinicalTrials.gov processed this record on October 29, 2014