Clinical trial NCT01127217: Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Stage 2 Hypertension
Official title: The Multicenter, Randomized, Double Blind Phase 3 Clinical Trial to Compare Efficacy and Safety of Combination of Amlodipine and Losartan Compared to Amlodipine Monotherapy in Patients With Stage 2 Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: amlodipine
losartan
hypertension
stage 2
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2010-05-20
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and amlodipine monotherapy for treatment of Stage 2 hypertensive patients.


Eligibility criteria: Inclusion Criteria:

* 18 aged or over
* Patients with blood pressure measured at Visit 1; MSSBP≤180mmHg and MSDBP≤110 mmHg if on anti-hypertensive drugs, 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg if not on anti-hypertensive drugs
* Patients with blood pressure measured at Visit 2 were 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg

Exclusion Criteria:

* Inability to stop all prior anti-hypertensive drugs safely during wash out period of 3 to 7 days
* ≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening
* History of hypersensitivity to dihydropyridines, angiotensin II receptor blockers or thiazide diuretics
* Secondary hypertension or suspected to be
* Continuously took medicinal drugs that might affect blood pressure rather than anti-hypertensive drugs more than 3 months
* Type 2 diabetes mellitus which is not controlled or with type 1 diabetes mellitus
* History of severe neurovascular disease, severe heart disease
* Known as moderate or malignant retinopathy.
* Renal diseases; serum creatinine ≥ 2mg/dl
* Hepatic diseases; increase in ALT or AST ≥ 2xUNL
* Anuria
* Hyponatremia/hypokalemia or hypercalcemia
* Active Gout
* Surgical or medical diseases which might significantly change ADME of medicines
* History of malignant tumor
* Autoimmune diseases
* History of alcohol or drug abuse
* Positive to pregnancy test, nursing mother, woman with an intention of pregnancy
* Considered inappropriate to participate in the clinical trial with any reason, based on investigator's decision

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in MSSBP
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Change from baseline in MSSBP
timeFrame: Baseline, Week 2 and 8
measure: Change from baseline MSDBP
timeFrame: Baseline, Week 2, 6, and 8
measure: Blood pressure responder rate
timeFrame: Baseline, Week 2, 6, 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: 8 Sites
Study officials:
References:
citation: Kim SH, Ryu KH, Lee NH, Kang JH, Kim WS, Park SW, Lee HY, Kim JJ, Ahn YK, Suh SY. Efficacy of fixed-dose amlodipine and losartan combination compared with amlodipine monotherapy in stage 2 hypertension: a randomized, double blind, multicenter study. BMC Res Notes. 2011 Oct 28;4:461. doi: 10.1186/1756-0500-4-461.