Status:
COMPLETED
Administration Time-dependent Antihypertensive Effects of Low Dose Aspirin in Well-controlled Hypertensive Patients
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Collaborating Sponsors:
Kyungpook National University Hospital
The Catholic University of Korea
Conditions:
Well-controlled Hypertension
Eligibility:
All Genders
30-70 years
Phase:
PHASE4
Brief 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
Detailed Description
Recent studies showed that low dose aspirin exerts a significant administration time-dependent effect on blood pressure in previously untreated hypertensive patients. However, this effect has not been...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
191 Patients enrolled
Trial Details
Trial ID
NCT00386529
Start Date
September 1 2006
End Date
August 1 2008
Last Update
December 15 2010
Active Locations (1)
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1
Kyungpook National University Hospital
Daegu, South Korea, 700-721