Administration Time-dependent Antihypertensive Effects of Low Dose Aspirin in Well-controlled Hypertensive Patients

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the influence of aspirin on blood pressure in well-controlled hypertensive patients who receive low dose aspirin at different times of the day

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boryung Pharmaceutical Co., Ltd
• Collaborators: Cheil General Hospital and Women's Healthcare Center; Cheil General Hospital and Women’s Healthcare Center; Inje University; Keimyung University; Kyungpook National University; Kyungpook National University Hospital; Seoul National University Bundang Hospital; Severance Hospital; The Catholic University of Korea; Yeungnam University; Yeungnam University Hospital
• Treatments: Antihypertensive Agents; Aspirin

Criteria

Inclusion Criteria:

• Age : 30 - 70 (inclusive)

• Essential hypertension without complication

• Well-controlled blood pressure over 3 months with same antihypertensive medication without changes in dose and frequency

• Averages of two consecutive sitting diastolic and systolic blood pressures are <90 mmHg and <140 mmHg, respectively at screening and visit 1

• Differences in sitting diastolic and systolic blood pressures between screening and visit 1 are 10 mmHg and 20 mmHg, respectively.

• Willing and able to give informed consent

Exclusion Criteria:

• patients with sitting diastolic blood pressure < 70 mmHg

• patients with secondary or malignant hypertension

• patients with complication or high risk of complication

• proven coronary artery or peripheral vascular diseases

• Framingham CHD Risk Score (10 years) 20

• Fasting blood glucose 110 mg/dl

• Hyperlipidemia under treatment or treatment required

• patients with myocardial infarction or severe cerebrovascular disorder in last 6 months

• patients with chronic renal insufficiency

• patients with unstable angina

• patients with severe left ventricular abnormalities or valvular defect

• patients with bradycardia(pulse rate < 50 times/min) or chronic tachycardia (pulse rate 100 times/min), second degree AV-block

• SGOT, SGPT> 2.5 times upper limit range or serum creatinine > 1.5 times upper limit range

• patients with unresolved malignant tumor or systemic infection

• lactating or pregnant females or females of childbearing potential who do not undergo hysterectomy or are not willing to use "effective" method of contraception.

• known hypersensitivities to the investigational drug

• patients judged to have alcohol or other drug abuse by the investigator

• patients who takes contraindicated drug at study entry (visit 1) or needs to contraindicated drug throughout the study period(if judged by the investigator not to influence on the study due to the temporal administration etc.)

• patients judged to be inappropriate for this study be the investigator

• patients with gastrointestinal troubles to NSAIDs