Peripheral Artery Disease With Intermittent ClaudicationPhase 4NCT02373462
Effect of olmesaRtan on Walking distancE and quaLIty of lifE in Peripheral Artery Disease Patients With Hypertension Treated For Intermittent Claudication (RELIEF)
A Phase 4 study testing Olmesartan and other anti-hypertensive drug in people with Peripheral Artery Disease With Intermittent Claudication, run by Yonsei University at 1 site in South Korea.
Trial summary
To study the effect of olmesartan on walking distance and quality of life in peripheral artery disease patients with hypertension treated For intermittent claudication. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Peripheral Artery Disease With Intermittent Claudication
- What is being tested?
- Olmesartan and other anti-hypertensive drug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Aug 2015to 17 Nov 2015
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 20 and 85 years at visit 1
- Patients with ankle-brachial index (ABI) of less than 0.9 in one or both legs with history of intermittent claudication stable for the previous 6 months
- Patients whose statins, anti hypertensive medications and antiplatelet medications are stable for the past 6 months. Statins and cilostazol are allowed but needs to be stable for the past 6 months (diabetic medications may be changed)
- Patients whose blood pressure is more than 140/90 mmHg with/without anti-hypertension treatment
Who cannot join
- Blood pressure of more than 180/110 mmHg
- Patients taking ARBs or ACE inhibitors treatment for at least 6 months before
- Patients taking aldosterone receptor antagonists at least 6 months before
- Patients with serum creatinine of more than 3 mg/dL
- serum potassium (K+) > 5.5mg/dl
- History of bilateral renal artery stenosis
Show all 11Show fewer
- History of acute coronary syndrome or heart failure hospitalization within 6 months
- Peripheral arterial revascularization planned within 1 month
- Critical limb ischemia
- Patients with impaired cognition (e.g. dementia)
- pregnancy or women at age of childbearing potential
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiology, Department of Internal Medicine, Severance Hospital
Seoul, 120-752
About this study
To study the effect of olmesartan on walking distance and quality of life in peripheral artery disease patients with hypertension treated For intermittent claudication.
- Being tested
- Olmesartan, other anti-hypertensive drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlmesartanDrug
other anti-hypertensive drugDrug
CCB, diuretics, alpha blocker, direct vasodilator, beta blocker
| Study group | Role | What they receive |
|---|---|---|
| olmesartan group | Experimental | olmesartan (20mg qd then 40mg qd for titrating BP <140/90 mmHg) Receives: Drug: Olmesartan |
| other group | Active comparator | other anti-hypertensive drug (titrating BP <140/90 mmHg) Receives: Drug: other anti-hypertensive drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain free maximum walking distance and time
Effect of olmesartan in maximum, pain free walking distance \& time
Measured: 12th week
Secondary outcomes (1)
Quality of life as measured by questionnaires
Effect of olmesartan in quality of life (WIQ, SF-36)
Measured: 24th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study start25 Aug 2015
- Primary completion17 Nov 2015
- Study completion17 Nov 2015
Why it stopped: The data of the paper referenced in the preparation of the protocols in this task were manipulated and the paper was withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery Disease With Intermittent ClaudicationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373462
- Sponsor's protocol ID
- 4-2014-0888
- Status last verified
- Jan 2019
- First submitted
- 14 Feb 2015
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of olmesaRtan on Walking distancE and quaLIty of lifE in Peripheral Artery Disease Patients With Hypertension Treated For Intermittent Claudication (RELIEF)
- ClinicalTrials.gov ID
- NCT02373462
- Acronym / sponsor ID
- 4-2014-0888
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The data of the paper referenced in the preparation of the protocols in this task were manipulated and the paper was withdrawn.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 25 Aug 2015 (actual)
- Primary completion
- 17 Nov 2015 (actual)
- Study completion
- 17 Nov 2015 (actual)
- First posted
- 27 Feb 2015 (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.
To study the effect of olmesartan on walking distance and quality of life in peripheral artery disease patients with hypertension treated For intermittent claudication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| olmesartan group | Experimental | Drug: Olmesartanolmesartan (20mg qd then 40mg qd for titrating BP <140/90 mmHg) |
| other group | Active comparator | Drug: other anti-hypertensive drugother anti-hypertensive drug (titrating BP <140/90 mmHg) |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 20 and 85 years at visit 1
- Patients with ankle-brachial index (ABI) of less than 0.9 in one or both legs with history of intermittent claudication stable for the previous 6 months
- Patients whose statins, anti hypertensive medications and antiplatelet medications are stable for the past 6 months. Statins and cilostazol are allowed but needs to be stable for the past 6 months (diabetic medications may be changed)
- Patients whose blood pressure is more than 140/90 mmHg with/without anti-hypertension treatment
Key exclusion criteria (11 listed)
- Blood pressure of more than 180/110 mmHg
- Patients taking ARBs or ACE inhibitors treatment for at least 6 months before
- Patients taking aldosterone receptor antagonists at least 6 months before
- Patients with serum creatinine of more than 3 mg/dL
- serum potassium (K+) > 5.5mg/dl
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 |
|---|---|---|
| Olmesartan | Drug | olmesartan group |
| other anti-hypertensive drugCCB, diuretics, alpha blocker, direct vasodilator, beta blocker | Drug | other group |
Primary outcome
Pain free maximum walking distance and time
Time frame: 12th week
Effect of olmesartan in maximum, pain free walking distance \& time
1 secondary outcome
Quality of life as measured by questionnaires
Time frame: 24th week
Results and safety
The study was stopped early (reason given: The data of the paper referenced in the preparation of the protocols in this task were manipulated and the paper was withdrawn.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Olmesartan and other anti-hypertensive drug in people with Peripheral Artery Disease With Intermittent Claudication, run by Yonsei University 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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 28 Jan 2019. 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 was stopped early (reason given: The data of the paper referenced in the preparation of the protocols in this task were manipulated and the paper was withdrawn.). Results are not available in the source record.
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?
Pain free maximum walking distance and time (time frame: 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2019.