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

Information source: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Amlodipine plus Losartan (Drug); Amlodipine (Drug); Losartan (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Hanmi Pharmaceutical Company Limited

Official(s) and/or principal investigator(s):
Seung-Yun Cho, M.D., Ph.D., Principal Investigator, Affiliation: Severance Hospital

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.

Clinical Details

Official title: An 8-week, Multicenter, Randomized, Double-blind, Factorial Phase II Study to Evaluate Dose-response Relationship of Amlodipine and Losartan Combination in Patients With Essential Hypertension.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Average changes from baseline in sitDBP

Secondary outcome:

Average changes from baseline in sitDBP

Average changes from baseline in sitSBP

Blood pressure responder rate

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients aged between 18 and 75

- Patients with essential hypertension {95 mmHg ≤ sitDBP< 115 mmHg at the end of

placebo run-in treatment period} Exclusion Criteria:

- 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

Locations and Contacts

14 sites in Korea, Seoul, Busan, etc., Korea, Republic of
Additional Information

Starting date: May 2007
Last updated: July 17, 2009

Page last updated: August 20, 2015

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