Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Stage 2 Hypertension

NCT01127217 | Completed Phase 3

• 1 other identifier: HM-ALOS-303
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

amlodipine; losartan; hypertension; stage 2

Outcome Measures

Primary Outcomes (1)

• Change from baseline in MSSBP

  Baseline, Week 6

Secondary Outcomes (3)

• Change from baseline in MSSBP

  Baseline, Week 2 and 8

• Change from baseline MSDBP

  Baseline, Week 2, 6, and 8

• Blood pressure responder rate

  Baseline, Week 2, 6, 8

Study Arms (2)

amlodipine/losartan

EXPERIMENTAL

Drug: amlodipine/losartan

amlodipine

ACTIVE COMPARATOR

Drug: amlodipine

Interventions

amlodipine/losartan DRUG

amlodipine 5mg/losartan 50mg, amlodipine 10mg/losartan 50mg (+HCTZ 12.5mg)

Also known as: amosartan

amlodipine/losartan

amlodipine DRUG

amlodipine 5mg, amlodipine 10mg (+ HCTZ 12.5mg)

Also known as: amodipin(amlodipine camsylate)

amlodipine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

8 Sites

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 22035131 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

amlodipine-losartan drug combination; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 19, 2010
• First Posted: May 20, 2010
• Study Start: May 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: September 14, 2010

Record last verified: 2010-09

Locations

KR (1)