Efficacy and Safety of Amlodipine and Losartan in Patients With Essential Hypertension

NCT00942344 | Completed Phase 2

• 1 other identifier: HM-ALOS-201
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of fixed combination of amlodipine(5mg or 10mg) and losartan (50 mg or 100 mg), amlodipine and losartan alone in reducing blood pressure. The study will investigate the dose response relationship for the combinations and monotherapies.

Conditions

Hypertension

Keywords

Amlodipine; Losartan; Hypertension

Outcome Measures

Primary Outcomes (1)

• Average changes from baseline in sitDBP

  Week 8

Secondary Outcomes (3)

• Average changes from baseline in sitDBP

  Week 4

• Average changes from baseline in sitSBP

  Week 4, 8

• Blood pressure responder rate

  Week 4, 8

Interventions

Amlodipine plus Losartan DRUG

amlodipine/losartan 5/50mg, 5/100mg, 10/50mg, 10/100mg

Also known as: Amosartan

Amlodipine DRUG

amlodipine 5mg, 10mg

Losartan DRUG

Losartan 50mg, 100mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18 and 75
• Patients with essential hypertension {95 mmHg ≤ sitDBP\< 115 mmHg at the end of placebo run-in treatment period}

You may not qualify if:

• Patients with mean sitSBP ≥ 200 mmHg
• Patients with known hypersensitivity to Dihydropyridine or angiotensin II receptor blockers
• Patients with secondary hypertension or suspected secondary hypertension
• Patients with malignant hypertension
• Patients who have received any medications with possible interactions with study drugs
• Patients with uncontrolled diabetes
• Patients with severe heart disease or severe cerebrovascular disease
• Patients with clinically significant hematological test results, renal disease (serum creatinine) or liver disease (ALT or AST)
• Patients with a history of malignant disease
• Patients with a history of autoimmune disease
• Women with a positive pregnancy test result, breast feeding or intention of pregnancy during the trial
• Patients inappropriate to be included in study population due to other reasons at the discretion of the investigator

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

14 sites in Korea

Seoul, Busan, Etc., South Korea

Location

Related Publications (1)

• Park CG, Youn HJ, Chae SC, Yang JY, Kim MH, Hong TJ, Kim CH, Kim JJ, Hong BK, Jeong JW, Park SH, Kwan J, Choi YJ, Cho SY. Evaluation of the dose-response relationship of amlodipine and losartan combination in patients with essential hypertension: an 8-week, randomized, double-blind, factorial, phase II, multicenter study. Am J Cardiovasc Drugs. 2012 Feb 1;12(1):35-47. doi: 10.2165/11597170-000000000-00000.

  PMID: 22217192 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine; Losartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Tetrazoles

Study Officials

• Seung-Yun Cho, M.D., Ph.D.

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 17, 2009
• First Posted: July 20, 2009
• Study Start: May 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 20, 2009

Record last verified: 2009-07

Locations

KR (1)