Rancomized controlled trial comparing peripheral edema after treatment with S(-)-amlodipine and amlodpine besylate

For 12-Weeks, Multi-center, Randomized, Double-blind, Parallel Designed, Clinical Study to Evaluate the Ankle Edema Formation of Lodien tablets vs. Norvasc tablets in Female Patients with Essential Hypertension

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000450

Enrollment

Registered

2012-05-30

Start date

2010-01-04

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Newly diagnosed patients with essential hypertension were initially screened and observed for 2 weeks with 2 placebo formulations of the study drugs (S(-)-amlodipine nicotinate and racemic amlo

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Patients with essential hypertension (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg) were eligible. Patients receiving other antihypertensive medications had to discontinue their previous medications and have a blood pressure over 140/90 mmHg and under 180/110 mmHg after the 2 week placebo run-in period.

Exclusion criteria

Exclusion criteria: secondary hypertension; angina pectoris, myocardial infarction, cerebrovascular disease, or clinically significant arrhythmia within the past 6 months; abnormal laboratory test results (serum creatinine levels > 1.5 times the upper limit of normal, serum aspartate aminotransferase of alanine aminotransferase levels >2 times the upper limit of normal); uncontrolled diabetes mellitus (HbA1c = 9%) or use of insulin; and use of antihypertensive drugs other than the study agents. Women of child-bearing age were required to have a negative urine pregnancy test before enrollment, and must use an acceptable method of birth control.

Design outcomes

Primary

Measure	Time frame
Ankle Foot Volume after 12weeks of treatment	—

Secondary

Measure	Time frame
Changes in sitting systolic and diastolic blood pressure after 12 weeks of treatment	—

Countries

Korea, Republic of

Contacts

Public ContactByung Hee Oh

Seoul National University Hospital

Outcome results