Arterial and Arteriolar DisordersPhase 4NCT01922687
Amlodipine Plus/Minus Atorvastatin for Protection of Arteries
A Phase 4 study testing amlodipine plus atorvastatin (Caduet) and amlodipine (Norvasc) in people with Arterial and Arteriolar Disorders, run by Shanghai Institute of Hypertension at 1 site in China.
Trial summary
The primary objective of this study is to test the hypothesis that amlodipine plus atorvastatin given in a single tablet (Caduet), compared with amlodipine alone (Norvasc), has a stronger effect in protection of arterial structure and function. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Arterial and Arteriolar Disorders
- What is being tested?
- amlodipine plus atorvastatin (Caduet) and amlodipine (Norvasc)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteChina
- Study dates
- Apr 2011to Dec 2014
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women or men, aged from 40 to 75 years;
- Women with child-bearing potential should apply an adequate non-pharmacological contraceptive technique;
- Untreated patients or those on a single antihypertensive drug (except calcium channel blocker ) but with an uncontrolled blood pressure on conventional measurement, ranging from 140 to 179 mm Hg systolic or from 90 to 109 mm Hg diastolic. The conventional blood pressure is the average of 3 consecutive measurements in the sitting position or a single visit.
- The 24 h ambulatory blood pressure should be at least 130 mm Hg systolic or 80 mm Hg diastolic, or higher;
- Fasting total cholesterol concentration ranging from 4.14 to 6.22 mmol/L (160 to 240 mg/dL);
- Endothelium-dependent flow-mediated dilatation (FMD) below 10%;
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- Serum activity of aspartate aminotransferase (AST), alanine aminotransferase (ALT), and creatine kinase (CK) should be within the normal range;
- Patients should not be on treatment with statins or other lipid-lowering drugs within 3 months of randomization;
- The patients should sign the informed consent form prior to the participation in the trial at the first visit;
- Patients should be independent and likely to adhere to the study protocol.
Who cannot join
- Secondary hypertension;
- Low-density lipoprotein cholesterol (LDL-C) below 2.59 mmol/L (100mg/dL);
- Renal dysfunction defined as eGFR<60ml/min/1.73m2;
- Current treatment with specific drugs or diets, such as fibrates (especially gemfibrozil), verapamil, amiodarone, grapefruit juice;
- Excessive alcohol consumption defined as drinking more than 1L/day;
- Stroke within 2 years of randomization or myocardial infarction occurred previous;
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- Known contra-indications to a dihydropyridine calcium channel blocker or statins;
- Any life threatening condition;
- Current participation in another trial or trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Institute of Hypertension
Shanghai, Shanghai Municipality, 200025
Pingjin Gao, 64370045 ext. 610903, gaopingjin@yahoo.com.cn
Pingjin Gao
About this study
The primary objective of this study is to test the hypothesis that amlodipine plus atorvastatin given in a single tablet (Caduet), compared with amlodipine alone (Norvasc), has a stronger effect in protection of arterial structure and function.
- Conditions
- Arterial and Arteriolar Disorders
- Being tested
- amlodipine plus atorvastatin (Caduet), amlodipine (Norvasc)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amlodipine plus atorvastatin (Caduet)Drug
amlodipine (Norvasc)Drug
| Study group | Role | What they receive |
|---|---|---|
| Amlodipine Plus Atorvastatin (Caduet) | Experimental | amlodipine plus atorvastatin in a single tablet (Caduet, Pfizer, USA) was given once daily Receives: Drug: amlodipine plus atorvastatin (Caduet) |
| Amlodipine (Norvasc) | Active comparator | amlodipine(Norvasc, Pfizer, USA) given once daily Receives: Drug: amlodipine (Norvasc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
flow-mediated dilation (FMD)
After 12-week maintenance treatment or at 24-week final visit.
Measured: 12-24 weeks
Secondary outcomes (6)
pulse wave velocity (cf-PWV, ba-PWV)
After 12-week maintenance treatment or at 24-week final visit.
Measured: 12-24 weeks
liver function
After 6-week maintenance treatment or at 24-week final visit.
Intolerable adverse events which may or may not be related to the trial treatment, including:
- Levels of AST or ALT more than three times the upper limit of normal;
- Myalgia symptoms appear with no or only a moderate increase in CK (3 to 10 times above upper limit of normal), but repeated measurements of CK is progressively increasing;
- Myalgia symptoms appear, the concentration of CK is 10 times higher than the upper limit of normal.
Measured: 6-24weeks
ankle-brachial index (ABI)
After 12-week maintenance treatment or at 24-week final visit.
Measured: 12-24 weeks
augmentation index (AIx)
After 12-week maintenance treatment or at 24-week final visit.
Measured: 12-24 weeks
carotid intima-media thickness (IMT)
After 12-week maintenance treatment or at 24-week final visit.
Measured: 12-24 weeks
cholesterol level
After 12-week maintenance treatment or at 24-week final visit.
Measured: 12-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startApr 2011
- Primary completionMar 2014 (estimated)
- Study completionDec 2014 (estimated)
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 Arterial and Arteriolar DisordersStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute of Hypertension
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Yang, Shanghai Institute of Hypertension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922687
- Sponsor's protocol ID
- Ruijin2010No.14
- Status last verified
- Aug 2013
- First submitted
- 30 Jul 2013
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pingjin Gao
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amlodipine Plus/Minus Atorvastatin for Protection of Arteries
- ClinicalTrials.gov ID
- NCT01922687
- Acronym / sponsor ID
- Ruijin2010No.14
- Conditions
- Arterial and Arteriolar Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- Shanghai Institute of HypertensionUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 14 Aug 2013 (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 primary objective of this study is to test the hypothesis that amlodipine plus atorvastatin given in a single tablet (Caduet), compared with amlodipine alone (Norvasc), has a stronger effect in protection of arterial structure and function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amlodipine Plus Atorvastatin (Caduet) | Experimental | Drug: amlodipine plus atorvastatin (Caduet)amlodipine plus atorvastatin in a single tablet (Caduet, Pfizer, USA) was given once daily |
| Amlodipine (Norvasc) | Active comparator | Drug: amlodipine (Norvasc)amlodipine(Norvasc, Pfizer, USA) given once daily |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women or men, aged from 40 to 75 years;
- Women with child-bearing potential should apply an adequate non-pharmacological contraceptive technique;
- Untreated patients or those on a single antihypertensive drug (except calcium channel blocker ) but with an uncontrolled blood pressure on conventional measurement, ranging from 140 to 179 mm Hg systolic or from 90 to 109 mm Hg diastolic. The conventional blood pressure is the average of 3 consecutive measurements in the sitting position or a single visit.
- The 24 h ambulatory blood pressure should be at least 130 mm Hg systolic or 80 mm Hg diastolic, or higher;
- Fasting total cholesterol concentration ranging from 4.14 to 6.22 mmol/L (160 to 240 mg/dL);
Key exclusion criteria (9 listed)
- Secondary hypertension;
- Low-density lipoprotein cholesterol (LDL-C) below 2.59 mmol/L (100mg/dL);
- Renal dysfunction defined as eGFR<60ml/min/1.73m2;
- Current treatment with specific drugs or diets, such as fibrates (especially gemfibrozil), verapamil, amiodarone, grapefruit juice;
- Excessive alcohol consumption defined as drinking more than 1L/day;
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 |
|---|---|---|
| amlodipine plus atorvastatin (Caduet) | Drug | Amlodipine Plus Atorvastatin (Caduet) |
| amlodipine (Norvasc) | Drug | Amlodipine (Norvasc) |
Primary outcome
flow-mediated dilation (FMD)
Time frame: 12-24 weeks
After 12-week maintenance treatment or at 24-week final visit.
6 secondary outcomes
pulse wave velocity (cf-PWV, ba-PWV)
Time frame: 12-24 weeks
liver function
Time frame: 6-24weeks
ankle-brachial index (ABI)
Time frame: 12-24 weeks
augmentation index (AIx)
Time frame: 12-24 weeks
carotid intima-media thickness (IMT)
Time frame: 12-24 weeks
cholesterol level
Time frame: 12-24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
- BackgroundPingjin Gao
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.
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 amlodipine plus atorvastatin (Caduet) and amlodipine (Norvasc) in people with Arterial and Arteriolar Disorders, run by Shanghai Institute of Hypertension at 1 site in China.
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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Aug 2013. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Yang (64370045 ext. 661124, jesuisyang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
flow-mediated dilation (FMD) (time frame: 12-24 weeks). 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 NCT01922687, 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 14 Aug 2013.