Well-controlled HypertensionPhase 4NCT00386529
Administration Time-dependent Antihypertensive Effects of Low Dose Aspirin in Well-controlled Hypertensive Patients
A Phase 4 study testing Aspirin enteric coated pellests 100mg in people with Well-controlled Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Well-controlled Hypertension
- What is being tested?
- Aspirin enteric coated pellests 100mg
- How many people
- 191 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2006to Aug 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
Read the 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.
- Conditions
- Well-controlled Hypertension
- Being tested
- Aspirin enteric coated pellests 100mg
- Keywords
- low dose aspirin, Hypertension, administration time dependent effect
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin enteric coated pellests 100mgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionJan 2007
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Well-controlled HypertensionStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyungpook National University Hospital, 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 Hospital
- Investigators
- Shung Chull Chae, Professor, Study chair, Kyungpook National University HospitalDong Ju Choi, Professor, Principal investigator, Seoul National University Bundang HospitalDong Su Kim, Professor, Principal investigator, Inje UniversityJeong Bae Park, Professor, Principal investigator, Cheil General Hospital and Women's Healthcare CenterNam Sik Chung, Professor, Principal investigator, Severance HospitalSang Hong Baek, Professor, Principal investigator, The Catholic University of KoreaChang Wook Nam, Professor, Principal investigator, Keimyung University Dongsan Medical CenterYoung Jo Kim, Professor, Principal investigator, Yeungnam University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386529
- Sponsor's protocol ID
- AST-HT-01
- Status last verified
- Dec 2010
- First submitted
- 9 Oct 2006
- Last updated
- 15 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 10912743Magen 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.
PubMed 16034448Hermida 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.
PubMed 9360028Hermida 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.
PubMed 12623974Hypertension 2005;46[part2]:1060-1068
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00386529
- Acronym / sponsor ID
- AST-HT-01
- Conditions
- Well-controlled Hypertension
- Keywords
- low dose aspirin, Hypertension, administration time dependent effect
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Kyungpook National University Hospital, 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 Hospital
- Study start
- Sep 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 11 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin enteric coated pellests 100mg | Drug | – |
Primary outcome
the changes in diastolic blood pressure
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2010.
- Results publication: PubMed 10912743Avanzini 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.
- Results publication: PubMed 16034448Magen 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.
- Results publication: PubMed 9360028Hermida 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.
- Results publication: PubMed 12623974Hermida 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.
- Results publicationHypertension 2005;46[part2]:1060-1068
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shung Chull Chae, Professor study chair
Kyungpook National University Hospital
Dong Ju Choi, Professor principal investigator
Seoul National University Bundang Hospital
Dong Su Kim, Professor principal investigator
Inje University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin enteric coated pellests 100mg in people with Well-controlled Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the changes in diastolic blood pressure. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00386529, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2010.