MK-0954E Phase III Long-Term Study in Participants With Hypertension (MK-0954E-356)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01299376
First received: February 16, 2011
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

This study has two parts. In the first part, losartan potassium (+) hydrochlorothiazide (+) amlodipine besylate (MK-0954E [losartan/HCTZ/amlodipine]) will be evaluated for efficacy, safety and tolerability and to determine if losartan/HCTZ/amlodipine is better than losartan potassium (+) hydrochlorothiazide (MK-0954H [losartan/HCTZ]) for participants. In the second part, the safety and tolerability of long-term use of open-label losartan/HCTZ/amlodipine in participants with hypertension will be evaluated.


Condition Intervention Phase
Hypertension
Drug: losartan potassium (+) hydrochlorothiazide (+) amlodipine besylate (MK-0954E)
Drug: losartan potassium (+) hydrochlorothiazide
Drug: Placebo to MK-0954E
Drug: Placebo to losartan potassium (+) hydrochlorothiazide
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 MK-954H (L50/H12.5 mg) [PREMINENT®] and an Open-label, Long-term Clinical Trial to Study the Safety of MK-0954E

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: 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: 268
Study Start Date: January 2011
Study Completion Date: September 2012
Primary Completion Date: November 2011 (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 up to 52 weeks.
Drug: Placebo to losartan potassium (+) hydrochlorothiazide
One tablet containing placebo, orally, once daily, for 8 weeks.
Active Comparator: Losartan/HCTZ Treatment Arm Drug: losartan potassium (+) hydrochlorothiazide
One tablet containing 50 mg losartan potassium and 12.5 mg hydrochlorothiazide, 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 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 ≥ 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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01299376     History of Changes
Other Study ID Numbers: 0954E-356
Study First Received: February 16, 2011
Last Updated: October 24, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

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 August 26, 2014