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

NCT00386529 | Completed Phase 4 DMC

• 1 other identifier: AST-HT-01
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

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

Conditions

Well-controlled Hypertension

Keywords

low dose aspirin; Hypertension; administration time dependent effect

Outcome Measures

Primary Outcomes (1)

• the changes in diastolic blood pressure

Secondary Outcomes (3)

• 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

Interventions

Aspirin enteric coated pellests 100mg DRUG

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead
• Kyungpook National University Hospital: collaborator
• The Catholic University of Korea: collaborator
• Cheil General Hospital and Women's Healthcare Center: collaborator
• Inje University: collaborator
• Keimyung University: collaborator
• Seoul National University Bundang Hospital: collaborator
• Severance Hospital: collaborator
• Yeungnam University Hospital: collaborator

Study Sites (1)

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

Related Publications (5)

• Avanzini F, Palumbo G, Alli C, Roncaglioni MC, Ronchi E, Cristofari M, Capra A, Rossi S, Nosotti L, Costantini C, Pietrofeso R. Effects of low-dose aspirin on clinic and ambulatory blood pressure in treated hypertensive patients. Collaborative Group of the Primary Prevention Project (PPP)--Hypertension study. Am J Hypertens. 2000 Jun;13(6 Pt 1):611-6. doi: 10.1016/s0895-7061(00)00231-4.

  PMID: 10912743 RESULT

• Magen E, Viskoper JR, Mishal J, Priluk R, London D, Yosefy C. Effects of low-dose aspirin on blood pressure and endothelial function of treated hypertensive hypercholesterolaemic subjects. J Hum Hypertens. 2005 Sep;19(9):667-73. doi: 10.1038/sj.jhh.1001910.

  PMID: 16034448 RESULT

• Hermida RC, Fernandez JR, Ayala DE, Mojon A, Iglesias M. Influence of aspirin usage on blood pressure: dose and administration-time dependencies. Chronobiol Int. 1997 Nov;14(6):619-37. doi: 10.3109/07420529709001452.

  PMID: 9360028 RESULT

• Hermida RC, Ayala DE, Iglesias M. Administration time-dependent influence of aspirin on blood pressure in pregnant women. Hypertension. 2003 Mar;41(3 Pt 2):651-6. doi: 10.1161/01.HYP.0000047876.63997.EE. Epub 2002 Dec 9.

  PMID: 12623974 RESULT

• Hypertension 2005;46[part2]:1060-1068

  RESULT

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Shung Chull Chae, Professor

  Kyungpook National University Hospital

  STUDY CHAIR

• 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 Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 9, 2006
• First Posted: October 11, 2006
• Study Start: September 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: August 1, 2008
• Last Updated: December 15, 2010

Record last verified: 2010-12

Locations

KR (1)