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

This study has been completed.
Information provided by:
SK Chemicals Co.,Ltd. Identifier:
First received: February 7, 2006
Last updated: March 5, 2007
Last verified: September 2006

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
Drug: S-amlodipine gentisate
Drug: Amlodipine besylate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

No publications provided Identifier: NCT00289406     History of Changes
Other Study ID Numbers: SK310_III_2006
Study First Received: February 7, 2006
Last Updated: March 5, 2007
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by SK Chemicals Co.,Ltd.:

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents processed this record on November 20, 2014