ClinicalTrials.gg
Status unknownNCT01922687Updated Aug 14, 2013

Amlodipine Plus/Minus Atorvastatin for Protection of Arteries

A Phase 4 interventional study of amlodipine plus atorvastatin (Caduet) and amlodipine (Norvasc) in Arterial and Arteriolar Disorders, sponsored by Shanghai Institute of Hypertension. Status unknown at 1 site in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-08-14.

Sponsored by Shanghai Institute of Hypertension · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
109
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Arterial and Arteriolar Disorders
03

In context

Lead sponsor

Shanghai Institute of Hypertension is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Women or men, aged from 40 to 75 years;
  2. Women with child-bearing potential should apply an adequate non-pharmacological contraceptive technique;
  3. 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.
  4. The 24 h ambulatory blood pressure should be at least 130 mm Hg systolic or 80 mm Hg diastolic, or higher;
  5. Fasting total cholesterol concentration ranging from 4.14 to 6.22 mmol/L (160 to 240 mg/dL);
  6. Endothelium-dependent flow-mediated dilatation (FMD) below 10%;
  7. Serum activity of aspartate aminotransferase (AST), alanine aminotransferase (ALT), and creatine kinase (CK) should be within the normal range;
  8. Patients should not be on treatment with statins or other lipid-lowering drugs within 3 months of randomization;
  9. The patients should sign the informed consent form prior to the participation in the trial at the first visit;
  10. Patients should be independent and likely to adhere to the study protocol.

Exclusion criteria

Exclusion Criteria:

  1. Secondary hypertension;
  2. Low-density lipoprotein cholesterol (LDL-C) below 2.59 mmol/L (100mg/dL);
  3. Renal dysfunction defined as eGFR\<60ml/min/1.73m2;
  4. Current treatment with specific drugs or diets, such as fibrates (especially gemfibrozil), verapamil, amiodarone, grapefruit juice;
  5. Excessive alcohol consumption defined as drinking more than 1L/day;
  6. Stroke within 2 years of randomization or myocardial infarction occurred previous;
  7. Known contra-indications to a dihydropyridine calcium channel blocker or statins;
  8. Any life threatening condition;
  9. Current participation in another trial or trials.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
109 participants (estimated)

Study arms

  • Experimental
    Amlodipine Plus Atorvastatin (Caduet)

    amlodipine plus atorvastatin in a single tablet (Caduet, Pfizer, USA) was given once daily

    Drug: amlodipine plus atorvastatin (Caduet)

  • Active comparator
    Amlodipine (Norvasc)

    amlodipine(Norvasc, Pfizer, USA) given once daily

    Drug: amlodipine (Norvasc)

Interventions

06

What researchers measure

Primary outcomes

  1. flow-mediated dilation (FMD)

    After 12-week maintenance treatment or at 24-week final visit.

    Time frame: 12-24 weeks

Secondary outcomes

  1. pulse wave velocity (cf-PWV, ba-PWV)

    After 12-week maintenance treatment or at 24-week final visit.

    Time frame: 12-24 weeks

  2. 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: 1. Levels of AST or ALT more than three times the upper limit of normal; 2. 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; 3. Myalgia symptoms appear, the concentration of CK is 10 times higher than the upper limit of normal.

    Time frame: 6-24weeks

  3. ankle-brachial index (ABI)

    After 12-week maintenance treatment or at 24-week final visit.

    Time frame: 12-24 weeks

  4. augmentation index (AIx)

    After 12-week maintenance treatment or at 24-week final visit.

    Time frame: 12-24 weeks

  5. carotid intima-media thickness (IMT)

    After 12-week maintenance treatment or at 24-week final visit.

    Time frame: 12-24 weeks

  6. cholesterol level

    After 12-week maintenance treatment or at 24-week final visit.

    Time frame: 12-24 weeks

07

Study locations

1 of 1 sites recruiting
  • Shanghai Institute of Hypertension
    Shanghai, Shanghai Municipality 200025, China
    Recruiting
08

References and documents

Publications

  • Pingjin Gao
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01922687
Lead sponsor
Shanghai Institute of Hypertension
Responsible party
Yan Yang (Attending physician, Shanghai Institute of Hypertension) — Principal investigator
First posted
Aug 14, 2013
Start date
Apr 2011
Primary completion
Mar 2014 (estimated)
Completion
Dec 2014 (estimated)
Last update
Aug 14, 2013

Study contacts

Yan Yang
Contact
jesuisyang@163.com
64370045 ext. 661124

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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