Efficacy of Losartan + Amlodipine Compared to Amlodipine Alone in the Treatment of Uncontrolled H… (NCT01277822) | Clinical Trial Compass
CompletedPhase 4
Efficacy of Losartan + Amlodipine Compared to Amlodipine Alone in the Treatment of Uncontrolled High Blood Pressure (MK-0954F-399)
334 participantsStarted 2011-05-30
Plain-language summary
This study will determine whether using losartan and amlodipine together will be non-inferior in lowering blood pressure than amlodipine alone.
Who can participate
Age range18 Years – 80 Years
SexALL
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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.
What they're measuring
1
Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8