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Completed

NCT Number: NCT01277822

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Essential Hypertension Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Losartan (+) amlodipine

Drug

One tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks.

Other names: COZAAR XQ™

Placebo to match losartan/amlodipine tablets

Drug

One tablet containing placebo, orally, once daily, for 8 weeks.

Amlodipine camsylate

Drug

2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks.

Placebo to match amlodipine

Drug

2 tablets containing placebo, orally, once daily, for 8 weeks.

Primary outcomes

  1. Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8

    Time frame: Baseline and Week 8

    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.

Secondary outcomes

  1. Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4

    Time frame: Baseline and Week 4

    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.

  2. Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8

    Time frame: Baseline and Week 8

    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.

  3. Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4

    Time frame: Baseline and Week 4

    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.

  4. Percentage of Participants Who Achieve Target Blood Pressure at Week 8

    Time frame: Week 8

    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.

  5. Percentage of Participants Who Achieve Target Blood Pressure at Week 4

    Time frame: Week 4

    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.

  6. Percentage of Participants Who Had Peripheral Edema During the Study

    Time frame: up to 8 weeks

    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.

  7. Change From Baseline in Ankle Circumference at Week 8

    Time frame: Baseline and Week 8

    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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 17, 2011
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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