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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00289406
Recruitment Status : Completed
First Posted : February 9, 2006
Last Update Posted : March 6, 2007
Information provided by:
SK Chemicals Co.,Ltd.

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: S-amlodipine gentisate Drug: Amlodipine besylate Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : January 2006
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. The difference in mean changes from baseline in through sitting diastolic blood pressure after 8 weeks of treatment

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00289406

Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
SK Chemicals Co.,Ltd.
Principal Investigator: SK Chemicals Investigational Site Seoul, Professor SK Chemicals Investigational Site Identifier: NCT00289406     History of Changes
Other Study ID Numbers: SK310_III_2006
First Posted: February 9, 2006    Key Record Dates
Last Update Posted: March 6, 2007
Last Verified: September 2006

Keywords provided by SK Chemicals Co.,Ltd.:

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents