Type II HyperlipidaemiaPhase 2NCT00686010
Efficacy and Safety of JTT-705 300, 600 And 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia
A Phase 2 study testing JTT-705 300mg, JTT-705 600mg and JTT-705 900mg in people with Type II Hyperlipidaemia, run by Japan Tobacco Inc. at 1 site in Netherlands.
Trial summary
To demonstrate the effect of JTT-705 doses from 300 mg to 900 mg on the elevation of HDL-C and on the inhibition of CETP activity versus placebo, in patients presenting with mild dyslipidaemia. These objectives will be tested after 4 weeks of treatment. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Type II Hyperlipidaemia
- What is being tested?
- JTT-705 300mg, JTT-705 600mg and JTT-705 900mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2000to Jun 2001
- 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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with of Type II hyperlipidaemia
- Patients having lipid values as indicated below:
- HDL-C < 1.6 mmol/l
- TG < 4.5 mmol/l
- Male and females between 18 and 65 years old (If female must be post-menopausal, or pre-menopausal and surgically sterile or using an acceptable form of contraception)
Who cannot join
- Body Mass Index (BMI) > 35 kg/m²
- Pregnant, breast feeding, or woman with child bearing potential without an effective method of contraception
- Concomitant use of medications identified in the protocol
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam, Utrecht, Rotterdam, Nijmegen, Arnhem, Groningen, Dordrecht, Hoorn, Groningen
Amsterdam
About this study
Official title: A 4-Weeks Treatment, Randomised, Double-Blind, Parallel-Group Study Evaluating The Efficacy and Safety of JTT-705 300 to 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia
To demonstrate the effect of JTT-705 doses from 300 mg to 900 mg on the elevation of HDL-C and on the inhibition of CETP activity versus placebo, in patients presenting with mild dyslipidaemia. These objectives will be tested after 4 weeks of treatment.
- Conditions
- Type II Hyperlipidaemia
- Being tested
- Placebo, JTT-705 300mg, JTT-705 600mg, JTT-705 900mg
- Keywords
- CETP Inhibitor, HDL-C, LDL-C, Apolipoprotein
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo tablet, 3 tablets, oral, once daily after breakfast
JTT-705 300mgDrug
JTT-705 tablet, 1 tablet, oral, once daily, after breakfast. Placebo tablet, 2 tablets, oral, once daily, after breakfast.
JTT-705 600mgDrug
JTT-705 tablet, 2 tablets, oral, once daily, after breakfast. Placebo tablet, 1 tablet, oral, once daily, after breakfast
JTT-705 900mgDrug
JTT-705 tablet, 3 tablets, oral, once daily, after breakfast
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Drug: Placebo |
| 2 | Experimental | JTT-705 300mg Receives: Drug: JTT-705 300mg |
| 3 | Experimental | JTT-705 600mg Receives: Drug: JTT-705 600mg |
| 4 | Experimental | JTT-705 900mg Receives: Drug: JTT-705 900mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
%change from baseline in HDL-C, Inhibition of CETP activity
Measured: 4-weeks
Secondary outcomes (1)
%change from baseline in LDL-C and TC/HDL ratio
Measured: 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startMay 2000
- Primary completionJan 2001
- Study completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II HyperlipidaemiaStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Japan Tobacco Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686010
- Sponsor's protocol ID
- CAY2-1
- Status last verified
- May 2008
- First submitted
- 26 May 2008
- Last updated
- 29 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-Weeks Treatment, Randomised, Double-Blind, Parallel-Group Study Evaluating The Efficacy and Safety of JTT-705 300 to 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia
- ClinicalTrials.gov ID
- NCT00686010
- Acronym / sponsor ID
- CAY2-1
- Conditions
- Type II Hyperlipidaemia
- Keywords
- CETP Inhibitor, HDL-C, LDL-C, Apolipoprotein
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Japan Tobacco Inc.Industry (pharma, biotech, devices)
- Study start
- May 2000
- Primary completion
- Jan 2001 (actual)
- Study completion
- Jun 2001 (actual)
- First posted
- 29 May 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.
To demonstrate the effect of JTT-705 doses from 300 mg to 900 mg on the elevation of HDL-C and on the inhibition of CETP activity versus placebo, in patients presenting with mild dyslipidaemia. These objectives will be tested after 4 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo |
| 2 | Experimental | Drug: JTT-705 300mgJTT-705 300mg |
| 3 | Experimental | Drug: JTT-705 600mgJTT-705 600mg |
| 4 | Experimental | Drug: JTT-705 900mgJTT-705 900mg |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with of Type II hyperlipidaemia
- Patients having lipid values as indicated below:
- Male and females between 18 and 65 years old (If female must be post-menopausal, or pre-menopausal and surgically sterile or using an acceptable form of contraception)
Key exclusion criteria (3 listed)
- Body Mass Index (BMI) > 35 kg/m²
- Pregnant, breast feeding, or woman with child bearing potential without an effective method of contraception
- Concomitant use of medications identified in the protocol
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 |
|---|---|---|
| PlaceboPlacebo tablet, 3 tablets, oral, once daily after breakfast | Drug | 1 |
| JTT-705 300mgJTT-705 tablet, 1 tablet, oral, once daily, after breakfast. Placebo tablet, 2 tablets, oral, once daily, after breakfast. | Drug | 2 |
| JTT-705 600mgJTT-705 tablet, 2 tablets, oral, once daily, after breakfast. Placebo tablet, 1 tablet, oral, once daily, after breakfast | Drug | 3 |
| JTT-705 900mgJTT-705 tablet, 3 tablets, oral, once daily, after breakfast | Drug | 4 |
Primary outcome
%change from baseline in HDL-C, Inhibition of CETP activity
Time frame: 4-weeks
1 secondary outcome
%change from baseline in LDL-C and TC/HDL ratio
Time frame: 4-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 29 May 2008.
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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 2 study testing JTT-705 300mg, JTT-705 600mg and JTT-705 900mg in people with Type II Hyperlipidaemia, run by Japan Tobacco Inc. at 1 site in Netherlands.
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 5 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: finished, as of the sponsor's last update on 29 May 2008. 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 Netherlands. 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 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 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?
%change from baseline in HDL-C, Inhibition of CETP activity (time frame: 4-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 29 May 2008.