Phase 4
Completed N=334
Efficacy of Losartan + Amlodipine Compared to Amlodipine Alone in the Treatment of Uncontrolled High Blood Pressure (MK-0954F-399)
Source: ClinicalTrials.gov NCT01277822 ↗Enrolled (actual)
334
Serious AEs
3.3%
Results posted
Apr 2014
Primary outcomePrimary: Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 — -10.1; -8.8 mmHg — p=0.1339
Summary
This study will determine whether using losartan and amlodipine together will be non-inferior in lowering blood pressure than amlodipine alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 |
-10.1; -8.8 | 0.1339 |
| SECONDARY Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4 |
-9.3; -10.0 | 0.4478 |
| SECONDARY Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 |
-15.0; -12.7 | 0.0717 |
| SECONDARY Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4 |
-12.5; -12.3 | 0.8736 |
| SECONDARY Percentage of Participants Who Achieve Target Blood Pressure at Week 8 |
63.0; 58.8 | 0.2508 |
| SECONDARY Percentage of Participants Who Achieve Target Blood Pressure at Week 4 |
55.1; 61.5 | 0.2508 |
| SECONDARY Percentage of Participants Who Had Peripheral Edema During the Study |
6.5; 5.4 | 0.6646 |
| SECONDARY Change From Baseline in Ankle Circumference at Week 8 |
-0.6; -0.7; -0.5; -0.2 | 0.7911 |
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.
Data sourced from ClinicalTrials.gov (NCT01277822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.