Cardiac DiseasePhase 3NCT00244504
Moxonidine in Patients Undergoing Vascular Surgery
A Phase 3 study testing moxonidine in people with Cardiac Disease and Vascular Surgery, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Investigating the perioperative effect of moxonidine. In a randomized double-blind fashion, patients undergoing vascular surgery will receive moxonidine 0.2 mg or placebo from the day before surgery until day 4 after surgery. Holter-EKG for 48 h, starting just before surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease, Vascular Surgery
- What is being tested?
- moxonidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2002to Mar 2006
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- abdominal aortic or peripheral vascular surgery
Who cannot join
- unstable angina,
- severe symptomatic heart failure (NYHA IV)
- systolic blood pressure at rest < 100 mmHg
- bradycardia (<50/min)
- higher grade AV heart block
- creatinine clearance < 30 ml/min
- pregnancy
- no consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Small Doses of Moxonidine in Patients Undergoing Vascular Surgery
Investigating the perioperative effect of moxonidine. In a randomized double-blind fashion, patients undergoing vascular surgery will receive moxonidine 0.2 mg or placebo from the day before surgery until day 4 after surgery. Holter-EKG for 48 h, starting just before surgery. Repeated 12-lead EKG, measurements of Troponin I and BNP, clinical visitations, follow-up interviews at 6 and 12 months
- Conditions
- Cardiac Disease, Vascular Surgery
- Being tested
- moxonidine
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moxonidineDrug
Also called Physiotens
moxonidine 0.2 mg/d starting the morning of surgery until day 4 after surgery
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | moxonidine group Receives: Drug: moxonidine |
| II | Placebo comparator | placebo group Receives: Drug: moxonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
over-all mortality
Measured: 30 days and 12 months
Secondary outcomes (1)
Ischemia detected by Holter-ECG ST alterations or troponin T elevation
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2005 (estimated)
- Study startNov 2002
- Primary completionMar 2006
- Study completionMar 2006
Why it stopped: Study was stopped after pre-definied interim analysis because of no effects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Miodrag Filipovic, PD Dr., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244504
- Sponsor's protocol ID
- 158/01
- Status last verified
- Nov 2009
- First submitted
- 25 Oct 2005
- Last updated
- 10 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bolliger D, Seeberger MD, Lurati Buse GA, Christen P, Gurke L, Filipovic M. Randomized clinical trial of moxonidine in patients undergoing major vascular surgery. Br J Surg. 2007 Dec;94(12):1477-84. doi: 10.1002/bjs.6012.
PubMed 17968979
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Small Doses of Moxonidine in Patients Undergoing Vascular Surgery
- ClinicalTrials.gov ID
- NCT00244504
- Acronym / sponsor ID
- 158/01
- Conditions
- Cardiac Disease, Vascular Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped after pre-definied interim analysis because of no effects
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Nov 2002
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 26 Oct 2005 (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.
Investigating the perioperative effect of moxonidine. In a randomized double-blind fashion, patients undergoing vascular surgery will receive moxonidine 0.2 mg or placebo from the day before surgery until day 4 after surgery. Holter-EKG for 48 h, starting just before surgery. Repeated 12-lead EKG, measurements of Troponin I and BNP, clinical visitations, follow-up interviews at 6 and 12 months
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Drug: moxonidinemoxonidine group |
| II | Placebo comparator | Drug: moxonidineplacebo group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- abdominal aortic or peripheral vascular surgery
Key exclusion criteria (8 listed)
- unstable angina,
- severe symptomatic heart failure (NYHA IV)
- systolic blood pressure at rest < 100 mmHg
- bradycardia (<50/min)
- higher grade AV heart block
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 |
|---|---|---|
| moxonidineAlso: Physiotensmoxonidine 0.2 mg/d starting the morning of surgery until day 4 after surgery | Drug | I, II |
Primary outcome
over-all mortality
Time frame: 30 days and 12 months
1 secondary outcome
Ischemia detected by Holter-ECG ST alterations or troponin T elevation
Time frame: 7 days
Results and safety
The study was stopped early (reason given: Study was stopped after pre-definied interim analysis because of no effects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2009.
- Derived from this study: PubMed 17968979Bolliger D, Seeberger MD, Lurati Buse GA, Christen P, Gurke L, Filipovic M. Randomized clinical trial of moxonidine in patients undergoing major vascular surgery. Br J Surg. 2007 Dec;94(12):1477-84. doi: 10.1002/bjs.6012.
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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.
Miodrag Filipovic, PD Dr. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing moxonidine in people with Cardiac Disease and Vascular Surgery, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 inclusion and 8 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 10 Nov 2009. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: Study was stopped after pre-definied interim analysis because of no effects). 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?
over-all mortality (time frame: 30 days and 12 months). 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 NCT00244504, which also lists 1 linked publication.
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 10 Nov 2009.