HypercholesteremiaNCT00688454
C-Control: Efficacy and Safety of Therapy With Rosuvastatin in Statin-Naive and in Statin-Switched Patients
An observational study of Hypercholesteremia, run by AstraZeneca.
Trial summary
The study explores efficacy and safety of the lipid-lowering therapy with CRESTOR in statin-naive patients and in patients with previously unsuccessful statin therapy. This study was designed to investigate the dynamic of the lipid parameters and therapy tolerability during 8-10 weeks treatment with CRESTOR Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypercholesteremia
- How many people
- 3,392 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Jan 2008
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Statin-naive patients and unsuccessfully treated with other (non rosubastatin) statins patients
Who may be able to join
- Patients with hypercholesteremia who was never treated with statins before
- Patient with hypercholesteremia who was treated with a statin (other then rosuvastatin) but because of its adverse effects/insufficient action was switched to therapy with CRESTOR
Who cannot join
- None
About this study
The study explores efficacy and safety of the lipid-lowering therapy with CRESTOR in statin-naive patients and in patients with previously unsuccessful statin therapy. This study was designed to investigate the dynamic of the lipid parameters and therapy tolerability during 8-10 weeks treatment with CRESTOR
- Conditions
- Hypercholesteremia
- Keywords
- Hyperlipidemia, Rosuvastatin, Efficacy, tolerability, CRESTOR therapy
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pt with hypercholesteremia | Patients treated with CRESTOR because of hypercholesteremia |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-Cholesterin, HDL-Cholesterin, Triglycerides, Total Cholesterin
Measured: 3 visits within 10 weeks
Secondary outcomes (1)
Tolerability of CRESTOR-therapy
Measured: 3 visits within 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startFeb 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesteremiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 3,392 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688454
- Sponsor's protocol ID
- NIS-CCH-CRE-2007/1
- Status last verified
- Apr 2009
- First submitted
- 29 May 2008
- Last updated
- 9 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-Control: Efficacy and Safety of Therapy With Rosuvastatin in Statin-Naive and in Statin-Switched Patients
- ClinicalTrials.gov ID
- NCT00688454
- Acronym / sponsor ID
- NIS-CCH-CRE-2007/1
- Conditions
- Hypercholesteremia
- Keywords
- Hyperlipidemia, Rosuvastatin, Efficacy, tolerability, CRESTOR therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,392 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Study completion
- Jan 2008 (actual)
- First posted
- 3 Jun 2008 (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 study explores efficacy and safety of the lipid-lowering therapy with CRESTOR in statin-naive patients and in patients with previously unsuccessful statin therapy. This study was designed to investigate the dynamic of the lipid parameters and therapy tolerability during 8-10 weeks treatment with CRESTOR
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pt with hypercholesteremia | – | –Patients treated with CRESTOR because of hypercholesteremia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Statin-naive patients and unsuccessfully treated with other (non rosubastatin) statins patients
Key inclusion criteria (2 listed)
- Patients with hypercholesteremia who was never treated with statins before
- Patient with hypercholesteremia who was treated with a statin (other then rosuvastatin) but because of its adverse effects/insufficient action was switched to therapy with CRESTOR
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
LDL-Cholesterin, HDL-Cholesterin, Triglycerides, Total Cholesterin
Time frame: 3 visits within 10 weeks
1 secondary outcome
Tolerability of CRESTOR-therapy
Time frame: 3 visits within 10 weeks
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 9 Apr 2009.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesteremia, run by AstraZeneca.
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 2 inclusion and 1 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 9 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
LDL-Cholesterin, HDL-Cholesterin, Triglycerides, Total Cholesterin (time frame: 3 visits within 10 weeks). 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 9 Apr 2009.