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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01277822
First received: January 13, 2011
Last updated: May 19, 2014
Last verified: May 2014

January 13, 2011
May 19, 2014
May 2011
April 2013   (final data collection date for primary outcome measure)
Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
Diastolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.
Mean change in sitting diastolic blood pressure (MSDBP) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01277822 on ClinicalTrials.gov Archive Site
  • Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    Diastolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.
  • Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    Systolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.
  • Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    Systolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.
  • Percentage of Participants Who Achieve Target Blood Pressure at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Participants were evaluated at Week 8 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) <90mmHg or sitting systolic BP (sitSBP) <140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline.
  • Percentage of Participants Who Achieve Target Blood Pressure at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Participants were evaluated at Week 4 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) <90mmHg or sitting systolic BP (sitSBP) <140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline.
  • Percentage of Participants Who Had Peripheral Edema During the Study [ Time Frame: up to 8 weeks ] [ Designated as safety issue: Yes ]
    A pitting assessment of edema on both legs was performed at baseline and throughout the study. Participants were assessed in a seated position with both feet extended and the right ankle in a neutral dorsiflexion position. The index finger was pressed firmly over the bony prominence approximately 3cm proximal to the midpoint of the medial malleolus of the right ankle and will be held for three seconds. Presence of a residual indentation in the area after releasing pressure on the index finger was considered positive for pitting edema.
  • Change From Baseline in Ankle Circumference at Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: Yes ]
    Each ankle was marked with a semi-permanent marker at approximately 3 cm proximal to the midpoint of the medial malleolus to aid consistency in the performance of the measurements. Ankle circumference was measured in both ankles at baseline and Week 8 using a tension controlled tape to minimize error.
  • Mean change in sitting diastolic blood pressure (MSDBP) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Mean change in 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 ]
Not Provided
Not Provided
 
Efficacy of Losartan + Amlodipine Compared to Amlodipine Alone in the Treatment of Uncontrolled High Blood Pressure (MK-0954F-399)
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

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • 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 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.
  • Drug: Placebo to match amlodipine
    2 tablets containing placebo, orally, once daily, for 8 weeks.
  • Experimental: Losartan/amlodipine Treatment Arm
    One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
    Interventions:
    • Drug: Losartan (+) amlodipine
    • Drug: Placebo to match amlodipine
  • Active Comparator: Amlodipine Treatment Arm
    2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
    Interventions:
    • Drug: Placebo to match losartan/amlodipine tablets
    • Drug: Amlodipine camsylate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
334
April 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01277822
0954F-399
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP