Clinical trial NCT01277822: Efficacy of Losartan + Amlodipine Compared to Amlodipine Alone in the Treatment of Uncontrolled High Blood Pressure (MK-0954F-399)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
Uncontrolled hypertension
High blood pressure
Uncontrolled high blood pressure
Untreated high blood pressure
Untreated hypertension
Essential hypertension
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2011-01-17
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4
timeFrame: Baseline and Week 4
measure: Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
timeFrame: Baseline and Week 8
measure: Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4
timeFrame: Baseline and Week 4
measure: Percentage of Participants Who Achieve Target Blood Pressure at Week 8
timeFrame: Week 8
measure: Percentage of Participants Who Achieve Target Blood Pressure at Week 4
timeFrame: Week 4
measure: Percentage of Participants Who Had Peripheral Edema During the Study
timeFrame: up to 8 weeks
measure: Change From Baseline in Ankle Circumference at Week 8
timeFrame: Baseline and Week 8
Other outcomes:
Locations:
Study officials:
References: