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

This study has been completed.
Sponsor:
Collaborators:
Kyungpook National University
The Catholic University of Korea
Cheil General Hospital and Women’s Healthcare Center
Inje University
Keimyung University
Seoul National University Bundang Hospital
Severance Hospital
Yeungnam University
Information provided by:
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT00386529
First received: October 9, 2006
Last updated: December 14, 2010
Last verified: December 2010
  Purpose

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


Condition Intervention Phase
Well-controlled Hypertension
Drug: Aspirin enteric coated pellests 100mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Double-Blind Randomized, Cross-over, Active-control, Comparative Clinical Study to Evaluate the Administration Time-dependent Antihypertensive Effects of Low Dose Aspirin in Well-Controlled Hypertensive Patients (Phase IV)

Resource links provided by NLM:


Further study details as provided by Boryung Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • the changes in diastolic blood pressure

Secondary Outcome Measures:
  • the changes in systolic blood pressure
  • the trend in home blood pressure for medication
  • the comparison of the changes in systolic and diastolic pressure in dipper and non-dipper patients

Enrollment: 191
Study Start Date: September 2006
Study Completion Date: August 2008
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
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 confirmed in patients taking low-dose aspirin in combination with antihypertensive medications. A multi-center, double-blind randomized, cross-over, active-control, comparative clinical study will be conducted 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.

Approximately 192 patients will be enrolled over 4 months in 8 centers nationwide.

After placebo run-in period, all subjects will be randomized into one of the following 3 groups.

Group I & II will take low dose aspirin for treatment period (for first and second 12 weeks)on awakening or before bed time. Group III will take placebo for treatment period.

After first 12 weeks' treatment period, the subjects will be informed whether she/he belongs to Group III. This will be done without breaking the double blinding in the other 2 groups.

The primary objective will be the evaluation of the influence of aspirin on blood pressure in well-controlled hypertensive patients who receive low dose aspirin at different times of the day.

The secondary objectives will be 1) comparison of the administration time-dependent effects of low dose aspirin on blood pressure between dipper and non-dipper patients and 2) the evaluation of the effects of low dose aspirin in Korean hypertensive patients.

A sub-study will be conducted in 3 centers to evaluate the effect of aspirin on endothelial function in patients with well-controlled hypertension.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386529

Locations
Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of, 700-721
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Kyungpook National University
The Catholic University of Korea
Cheil General Hospital and Women’s Healthcare Center
Inje University
Keimyung University
Seoul National University Bundang Hospital
Severance Hospital
Yeungnam University
Investigators
Study Chair: Shung Chull Chae, Professor Kyungpook National University
Principal Investigator: Dong Ju Choi, Professor Seoul National University Bundang Hospital
Principal Investigator: Dong Su Kim, Professor Inje University
Principal Investigator: Jeong Bae Park, Professor Cheil General Hospital and Women’s Healthcare Center
Principal Investigator: Nam Sik Chung, Professor Severance Hospital
Principal Investigator: Sang Hong Baek, Professor The Catholic University of Korea
Principal Investigator: Chang Wook Nam, Professor Keimyung University Dongsan Medical Center
Principal Investigator: Young Jo Kim, Professor Yeungnam University
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00386529     History of Changes
Other Study ID Numbers: AST-HT-01
Study First Received: October 9, 2006
Last Updated: December 14, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Boryung Pharmaceutical Co., Ltd:
low dose aspirin
Hypertension
administration time dependent effect

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Antihypertensive Agents
Aspirin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014