NCT00289406

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2006

Completed
Last Updated

March 6, 2007

Status Verified

September 1, 2006

First QC Date

February 7, 2006

Last Update Submit

March 5, 2007

Conditions

Hypertension

Keywords

hypertension

Outcome Measures

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

Interventions

S-amlodipine gentisateDRUG
Amlodipine besylateDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SKChemicals

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • SK Chemicals Investigational Site Seoul, Professor

    SK Chemicals Investigational Site

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 7, 2006

First Posted

February 9, 2006

Study Start

January 1, 2006

Study Completion

February 1, 2006

Last Updated

March 6, 2007

Record last verified: 2006-09

Locations

KR(1)