Clinical trial NCT01922687: Amlodipine Plus/Minus Atorvastatin for Protection of Arteries
Official title: Amlodipine Plus/Minus Atorvastatin for Protection of Arteries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Arterial and Arteriolar Disorders
Lead sponsor: Shanghai Institute of Hypertension
Sponsor class: OTHER
First posted: 2013-08-14
Enrollment: 109
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

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.

Primary outcomes:
measure: flow-mediated dilation (FMD)
timeFrame: 12-24 weeks
Secondary outcomes:
measure: pulse wave velocity (cf-PWV, ba-PWV)
timeFrame: 12-24 weeks
measure: liver function
timeFrame: 6-24weeks
measure: ankle-brachial index (ABI)
timeFrame: 12-24 weeks
measure: augmentation index (AIx)
timeFrame: 12-24 weeks
measure: carotid intima-media thickness (IMT)
timeFrame: 12-24 weeks
measure: cholesterol level
timeFrame: 12-24 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Institute of Hypertension
state: Shanghai
Study officials:
References:
citation: Pingjin Gao