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Efficacy of Losartan + Amlodipine Compared to Amlodipine Alone in the Treatment of Uncontrolled High Blood Pressure (MK-0954F-399 AM3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01277822
First received: January 13, 2011
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

This study will determine whether using losartan and amlodipine together will be non-inferior in lowering blood pressure than amlodipine alone.


Condition Intervention Phase
Hypertension
 Drug: Losartan (+) amlodipine
Drug: Placebo to match losartan/amlodipine tablets
Drug: Amlodipine camsylate
Drug: Placebo to match amlodipine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The 8 Weeks, Multicenter, Randomized, Double-blind, Clinical Study To Evaluate Efficacy Of Treatment With Losartan/Amlodipine 100/5 mg Combination Compared To Amlodipine 10 mg Monotherapy In Hypertensive Patients Who Are Not Appropriately Respond To Amlodipine 5 mg Monotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

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

Secondary Outcome Measures:
  • Change in mean sitting diastolic blood pressure (MSDBP) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in mean sitting systolic blood pressure (MSSBP) [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
  • Number of participants who achieve target blood pressure [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
  • Incidence of peripheral edema during treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Change in peripheral edema measurements from baseline to end of treatment [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse experiences (AEs) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 334
Study Start Date: May 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Losartan/amlodipine Treatment Arm Drug: Losartan (+) amlodipine
One tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks.
Other Name: COZAAR XQ™
Drug: Placebo to match amlodipine
2 tablets containing placebo, orally, once daily, for 8 weeks.
Active Comparator: Amlodipine Treatment Arm Drug: Placebo to match losartan/amlodipine tablets
One tablet containing placebo, orally, once daily, for 8 weeks.
Drug: Amlodipine camsylate
2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Participants with essential hypertension:

    • who are on single drug therapy
    • who are newly diagnosed and not yet taking any drug therapy, or have not had any drug therapy for at least 2 weeks prior to entering study
    • who have blood pressure readings of 90mmHg ≤ MSDBP < 110mmHg and 140mmHg ≤ MSSBP <180mmHg after 2 weeks wash-out for patients on single agent.

  • Randomization (Visit 3)

    • After dosing of amlodipine 5mg for 6 weeks, blood pressure readings are:

      • 90mmHg ≤ MSDBP < 110mmHg and 140mmHg ≤ MSSBP < 180mmHg.

Exclusion criteria

  • Participant with MSDBP ≥ 110mmHg or MSSBP ≥ 180mmHg.
  • Participant currently taking ≥ 2 antihypertensive medications (note: fixed-dose combination medicine should be counted as the number of active ingredients).
  • Participant with known secondary hypertension of any etiology.
  • Participant with malignant hypertension or current evidence of impending or active malignant hypertension, including headache, papilledema, cardiac ischemia, or pulmonary congestion precipitated by elevated blood pressure.
  • Participant with known intolerance, contraindication or hypersensitivity to any component of dihydropyridines, angiotensin II receptor blockers.
  • Participant showing positive in pregnancy test, lactating woman, or woman who intends to get pregnant during the study period.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01277822     History of Changes
Other Study ID Numbers: 0954F-399
Study First Received: January 13, 2011
Last Updated: May 1, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Merck:
Hypertension
Uncontrolled hypertension
High blood pressure
Uncontrolled high blood pressure
 Untreated high blood pressure
Untreated hypertension
Essential hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Losartan
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 23, 2013