HypertensionPhase 2NCT00444834
A Study of Controlled-Release Carvedilol Compared to Immediate-Release Carvedilol in Patients With Primary Hypertension
A Phase 2 study testing Carvedilol in people with Hypertension, run by Egalet Ltd at 2 sites in Denmark.
Trial summary
The purpose of this study is to compare the efficacy of the Egalet® controlled release formulation to an immediate release Carvedilol tablet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Carvedilol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesDenmark
- Study dates
- Apr 2007to May 2007
- Phase
- Phase 2
- 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
- Have a diagnosis of mild or moderate primary hypertension
- Be able to tolerate a 2 week washout phase followed by a 2 week Placebo run- in phase
- Be minimum 18 years of age
Who cannot join
- Be intolerant to alfa- or beta-blockers
- Have secondary causes of hypertension
- Be taking more than two antihypertensive medications
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase II, Multi-center, Multiple-dose, Double-blind, Randomized, Crossover Study Comparing the Pharmacodynamic Effects of a Once-daily Controlled-Release Carvedilol (CRC; Egalet® Formulation) and an Immediate-Release Carvedilol (IRC) Formulation in Patients With Primary Hypertension
The purpose of this study is to compare the efficacy of the Egalet® controlled release formulation to an immediate release Carvedilol tablet.
- Conditions
- Hypertension
- Being tested
- Carvedilol
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvedilolDrug
50 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Egalet carvedilol Receives: Drug: Carvedilol |
| 2 | Active comparator | Coreg Receives: Drug: Carvedilol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline to 3 weeks treatment in systolic blood pressure at the end of five minutes of sub-maximal exercise
Measured: 15w
Secondary outcomes (2)
The change in Heart Rate from baseline to 3 weeks treatment measured at the end of five minutes of sub-maximal exercise
Measured: 15w
Safety
Measured: 15w
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionMay 2007
- Study completionMay 2007
Why it stopped: IMP supply
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egalet Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine Andersen, MSc Pharm, Study director, Egalet A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444834
- Sponsor's protocol ID
- CL-EG-006
- Other IDs
- EudraCT no.: 2006-006534-17
- Status last verified
- Aug 2016
- First submitted
- 7 Mar 2007
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multi-center, Multiple-dose, Double-blind, Randomized, Crossover Study Comparing the Pharmacodynamic Effects of a Once-daily Controlled-Release Carvedilol (CRC; Egalet® Formulation) and an Immediate-Release Carvedilol (IRC) Formulation in Patients With Primary Hypertension
- ClinicalTrials.gov ID
- NCT00444834
- Acronym / sponsor ID
- CL-EG-006
- Conditions
- Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IMP supply
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Egalet LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 8 Mar 2007 (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 compare the efficacy of the Egalet® controlled release formulation to an immediate release Carvedilol tablet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CarvedilolEgalet carvedilol |
| 2 | Active comparator | Drug: CarvedilolCoreg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a diagnosis of mild or moderate primary hypertension
- Be able to tolerate a 2 week washout phase followed by a 2 week Placebo run- in phase
- Be minimum 18 years of age
Key exclusion criteria (3 listed)
- Be intolerant to alfa- or beta-blockers
- Have secondary causes of hypertension
- Be taking more than two antihypertensive medications
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 |
|---|---|---|
| Carvedilol50 mg | Drug | 1, 2 |
Primary outcome
The change from baseline to 3 weeks treatment in systolic blood pressure at the end of five minutes of sub-maximal exercise
Time frame: 15w
2 secondary outcomes
The change in Heart Rate from baseline to 3 weeks treatment measured at the end of five minutes of sub-maximal exercise
Time frame: 15w
Safety
Time frame: 15w
Results and safety
The study was stopped early (reason given: IMP supply). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
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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.
Christine Andersen, MSc Pharm study director
Egalet A/S
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carvedilol in people with Hypertension, run by Egalet Ltd at 2 sites in Denmark.
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 3 inclusion and 3 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 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: IMP supply). 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?
The change from baseline to 3 weeks treatment in systolic blood pressure at the end of five minutes of sub-maximal exercise (time frame: 15w). 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 29 Aug 2016.