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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00460915
• Date of registration: 16/04/2007
• Primary sponsor: Korea University Guro Hospital
• Public title: Efficacy and Safety of Lacidipine and Amlodipine on Blood Pressure in Korean ISH Patients Aged 60 to 80 Years ELDER
• Scientific title: Korea University Guro Hospital
• Date of first enrolment: January 2007
• Target sample size: 204
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00460915
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Korea, Republic of

Contacts

• Name: Hong-seog Seo
• Affiliation: Korea University Guro Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female 55 to 80 years of age at screening

2. 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

3. The subject has a mean seated SBP at screening visit = 140mmHg (as measured by a
mercury sphygmomanometer)

4. Isolated systolic hypertension (ISH) patient (SBP= 140mmHg, DBP =90mmHg)

5. 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

6. The subject has given written informed consent

Exclusion Criteria:

- A subject will not be eligible for inclusion in this study if any of the following
criteria apply :

1. Mean seated SBP of > 180 mmHg at screening and during the study

2. Known or suspected secondary hypertension

3. The subject has anemia defined by hemoglobin concentration < 10.0 g/dL for male
or female

4. The subject has a hemoglobinopathy or peripheral vascular disease

5. 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

6. The subject has presence of unstable or severe angina, coronary insufficiency,
or any congestive heart failure requiring pharmacologic treatment

7. 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)

8. The subject has a clinically significant abnormality identified at screening
which in the judgement of the investigator makes the subject unsuitable for
inclusion in the study (e.g. physical examination, or electrocardiogram etc.)

9. Past medical history or concomitant disease of metabolic acidosis or diabetic
ketoacidosis

10. 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

11. Subject who is taking medication known to affect blood pressure

12. Known drug or alcohol dependency within 6 months prior to screening as
determined by the investigator

13. Has taken part in a clinical trial using a marketed product, investigational
drug or device within 1 month prior to screening.

14. Hypersensitivity to any component of lacidipine and amlodipine



Age minimum: 55 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Drug: Lacidipine & Amlodipine

Primary Outcome(s)

Change from baseline in the mean SBP at week 12

Secondary Outcome(s)

Change from baseline in the CRP at week 12

Change from baseline in the mean DBP at week 12

Secondary ID(s)

COL109776

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GlaxoSmithKline