Amlodipine Plus/Minus Atorvastatin for Protection of Arteries

Shanghai Institute of Hypertension

Status and phase: Unknown; Phase 4

Conditions: Arterial and Arteriolar Disorders

Treatments: Drug: amlodipine (Norvasc); Drug: amlodipine plus atorvastatin (Caduet)

Study type: Interventional

Funder types: Other

Identifiers

NCT01922687

Ruijin2010No.14

Details and patient eligibility

About

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.

Enrollment: 109 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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109 participants in 2 patient groups

Amlodipine Plus Atorvastatin (Caduet)

Experimental group

Description:

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

Treatment:

Drug: amlodipine plus atorvastatin (Caduet)

Amlodipine (Norvasc)

Active Comparator group

Description:

amlodipine(Norvasc, Pfizer, USA) given once daily

Treatment:

Drug: amlodipine (Norvasc)