Efficacy and Safety Study of S-Amlodipine Gentisate Compared to Amlodipine Besylate to Treat Mild-to-Moderate Hypertension

This study has been completed.

First Received: February 7, 2006 Last Updated: March 5, 2007 History of Changes

Sponsored by:	SK Chemicals Co.,Ltd.
Information provided by:	SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:	NCT00289406

Purpose

The goal of this study is to compare the antihypertensive effect and tolerability of S-amlodipine gentisate with those of amlodipine besylate in patients with mild to moderate hypertension.

Condition	Intervention	Phase
Hypertension	Drug: S-amlodipine gentisate Drug: Amlodipine besylate	Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate 2,5-Dihydroxybenzoic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An 8 Weeks, Multi-Center, Randomized, Double Blinded, Comparative Phase 3 Clinical Trial to Assess the Efficacy and Safety of S-Amlodipine Gentisate Compared to Amlodipine Besylate in Patients With Mild-to-Moderate Hypertension

Further study details as provided by SK Chemicals Co.,Ltd.:

Primary Outcome Measures:

The difference in mean changes from baseline in through sitting diastolic blood pressure after 8 weeks of treatment

Secondary Outcome Measures:

Mean changes in sitting systolic blood pressure; response rate (defined as the proportion of patients whose sDBP was ≤90mmHg or whose sDBP had decreased from baseline by ≥10 mmHg); changes in triglyceride and total cholesterol level of blood sample

Estimated Enrollment:	110
Study Start Date:	January 2006
Estimated Study Completion Date:	February 2006

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients are required to have a mean cuff sitting diastolic blood pressure of ≥90 and ≤109 mmHg after successful completion of the 2-week placebo run-in period

Exclusion Criteria:

any serious disorder that could limit the ability of the patient to participate in the study
significant cardiovascular disease (angina, myocardial infarction, cerebrovascular disease, or significant arrhythmia in the preceding 6 months)
uncontrolled diabetes mellitus (serum glucose level ≥140 mg/dl)
insulin dependent diabetes mellitus (type I)
secondary hypertension

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289406

Locations

Korea, Republic of
SKChemicals
Seoul, Korea, Republic of

Sponsors and Collaborators

SK Chemicals Co.,Ltd.

Investigators

Principal Investigator:

SK Chemicals Investigational Site Seoul, Professor

SK Chemicals Investigational Site

More Information

No publications provided

Study ID Numbers:	SK310_III_2006
Study First Received:	February 7, 2006
Last Updated:	March 5, 2007
ClinicalTrials.gov Identifier:	NCT00289406 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by SK Chemicals Co.,Ltd.:

hypertension

Study placed in the following topic categories:

Calcium, Dietary
Vasodilator Agents
Vascular Diseases
Calcium Channel Blockers

Cardiovascular Agents
Antihypertensive Agents
Amlodipine
Hypertension

Additional relevant MeSH terms:

Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Vascular Diseases
Calcium Channel Blockers

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Amlodipine
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009