Efficacy and Safety of Lacidipine and Amlodipine on Blood Pressure in Korean ISH Patients Aged 60 to 80 Years

NCT00460915 | Completed Phase 4

• 1 other identifier: COL109776
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective -To investigate the clinical effectiveness of lacidipine and amlodipine on systolic blood pressure (SBP) in Korean ISH patients aged 60 to 80 years. Secondary Objectives -To investigate the clinical effectiveness of lacidipine and amlodipine on diastolic blood pressure (DBP) in Korean ISH patients aged 60 to 80 years To demonstrate the effectiveness of lacidipine and amlodipine on endothelial function through measurement of markers of inflammation.

Conditions

Hypertension

Keywords

Lacidipine; Amlodipine

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the mean SBP at week 12

Secondary Outcomes (2)

• Change from baseline in the mean DBP at week 12

• Change from baseline in the CRP at week 12

Interventions

Lacidipine & Amlodipine DRUG

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 55 to 80 years of age at screening
• The subject has been newly diagnosed as essential hypertension or not treated in the past 2 weeks. If the subject took medication in the past 2 weeks, a wash-out period of at least 2 weeks will be completed prior to performing screening (week -2) assessments
• The subject has a mean seated SBP at screening visit ≥ 140mmHg (as measured by a mercury sphygmomanometer)
• Isolated systolic hypertension (ISH) patient (SBP≥ 140mmHg, DBP ≤90mmHg)
• If the subject is a female of child-bearing potential, she agrees to practice acceptable contraceptive measures during the study, and for 30 days after the last dose of study medication is taken
• The subject has given written informed consent

You may not qualify if:

• Mean seated SBP of \> 180 mmHg at screening and during the study
• Known or suspected secondary hypertension
• The subject has anemia defined by hemoglobin concentration \< 10.0 g/dL for male or female
• The subject has a hemoglobinopathy or peripheral vascular disease
• The subject has presence of clinically significant renal or hepatic disease (i.e., subjects with serum creatinine \> 1.4 mg/dL;ALT, AST, total bilirubin, or alkaline phosphatase \> 2.5 times the upper limit of the normal (ULN) reference range
• The subject has presence of unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring pharmacologic treatment
• The subject has a chronic disease requiring intermittent or chronic treatment with oral, intravenous, or intra-articular corticosteroids (i.e., only use of topical, inhaled or nasal corticosteroids is permissible)
• Past medical history or concomitant disease of metabolic acidosis or diabetic ketoacidosis
• The subject has a diagnosis of cancer (other than squamous or basal cell) in the past 3 years and is currently receiving treatment for the active cancer
• Subject who is taking medication known to affect blood pressure
• Known drug or alcohol dependency within 6 months prior to screening as determined by the investigator
• Has taken part in a clinical trial using a marketed product, investigational drug or device within 1 month prior to screening.
• Hypersensitivity to any component of lacidipine and amlodipine

Sponsors & Collaborators

• Korea University Guro Hospital: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Korea University Guro Hospital

Seoul, Seoul, 152-703, South Korea

Location

Related Publications (1)

• Na JO, Seo HS, Choi CU, Lim HE, Kim JW, Kim EJ, Han SW, Rha SW, Park CG, Oh DJ; ELDER investigators. Results of a 14-Week, Multicenter, Prospective, Randomized, Open-Label, Noninferiority Clinical Trial Comparing the Antihypertensive Effect and Edema Incidence of Lacidipine and Amlodipine in Older Korean Patients with Mild-to-Moderate Hypertension. Curr Ther Res Clin Exp. 2013 Jun;74:54-61. doi: 10.1016/j.curtheres.2013.02.001.

  PMID: 24384734 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

lacidipine; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hong-seog Seo

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 16, 2007
• First Posted: April 17, 2007
• Study Start: January 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: February 1, 2010
• Last Updated: March 2, 2010

Record last verified: 2009-11

Locations

KR (1)