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CompletedNCT00289406Updated Mar 6, 2007

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

A Phase 3 interventional study of S-amlodipine gentisate and Amlodipine besylate in Hypertension, sponsored by SK Chemicals Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-03-06.

Sponsored by SK Chemicals Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension

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Keywords

  • hypertension
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 110 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

SK Chemicals Co., Ltd. is the lead sponsor of 53 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
110 participants

Interventions

  • DrugS-amlodipine gentisate
  • DrugAmlodipine besylate
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  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

07

Study locations

1 site
  • SKChemicals
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00289406
Lead sponsor
SK Chemicals Co., Ltd.
First posted
Feb 9, 2006
Start date
Jan 2006
Completion
Feb 2006
Last update
Mar 6, 2007

Study contacts

SK Chemicals Investigational Site Seoul, Professor
principal investigator · SK Chemicals Investigational Site
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2006. You cannot join it, but the record below documents what was studied.

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