Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Essential Hypertension
- Registration Number
- NCT00940667
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief Summary
The purpose of this study is to evaluate of efficacy and safety of amlodipine plus losartan and amlodipine alone in patients with essential hypertension inadequately controlled on amlodipine monotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 185
Inclusion Criteria
- Patients over 18 years of age
- Essential hypertensive patients whose blood pressure is not controlled before the study (sit DBP ≥ 90 mmHg for drug-treated patient, sit DBP ≥ 95 mmHg for drug-naïve patient)
- Non-responder to 4 weeks treatment of amlodipine 5 mg monotherapy (sit DBP ≥ 90mmHg)
Exclusion Criteria
- mean sit SBP ≥ 200 mmHg or mean sit DBP ≥ 120 mmHg at screening
- mean sit SBP ≥ 180 mmHg or mean sit DBP ≥ 120 mmHg after 4 weeks of amlodipine 5 mg treatment
- has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers
- Secondary hypertensive patient or suspected to be
- Uncontrolled diabetes mellitus patients
- Severe heart disease or severe neurovascular disease
- Known as severe or malignant retinopathy
- Patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (ALT or AST)
- History of malignancy tumor
- History of autoimmune disease
- History of alcohol or drug abuse
- Positive to pregnancy test, nursing mother, has an intention on pregnancy
- Considered by investigator as not appropriate to participate in the clinical study with othe reason
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description amlodipine/losartan 5/50mg Amlodipine plus Losartan - amlodipine 5mg Amlodipine -
- Primary Outcome Measures
Name Time Method Change from baseline in mean sitting diastolic blood pressure Week 8
- Secondary Outcome Measures
Name Time Method Responder rate Week 4, 8 Change from baseline in mean sitting diastolic blood pressure Week 4 Change from baseline in mean sitting systolic blood pressure Week 4, 8
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the synergistic antihypertensive effect of amlodipine and losartan in NCT00940667?
How does amlodipine 5mg+losartan 50mg compare to amlodipine 10mg in managing resistant hypertension per Hanmi's Phase III trial?
Which biomarkers correlate with improved blood pressure control in amlodipine-losartan combination therapy for essential hypertension?
What adverse event profiles differentiate amlodipine monotherapy from amlodipine-losartan combination in Hanmi's NCT00940667 study?
How do CCB-ARB combinations like amlodipine-losartan influence the therapeutic landscape for hypertension compared to other dual-drug regimens?
Trial Locations
- Locations (1)
13 sites in Korea
🇰🇷Seoul, Busan, etc., Korea, Republic of
13 sites in Korea🇰🇷Seoul, Busan, etc., Korea, Republic of