Amlodipine Plus/Minus Atorvastatin for Protection of Arteries

Phase 4

• Conditions: Arterial and Arteriolar Disorders
• Interventions: Drug: amlodipine plus atorvastatin (Caduet); Drug: amlodipine (Norvasc)

• Registration Number: NCT01922687
• Lead Sponsor: Shanghai Institute of Hypertension

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2013-07-30
• Status Verified: 2013-08
• Study First Submitted QC: 2013-08-12
• Last Update Submitted: 2013-08-12
• Study First Posted: 2013-08-14
• Last Update Posted: 2013-08-14
• Primary Completion: 2014-03
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 109

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amlodipine Plus Atorvastatin (Caduet)	amlodipine plus atorvastatin (Caduet)	amlodipine plus atorvastatin in a single tablet (Caduet, Pfizer, USA) was given once daily
Amlodipine (Norvasc)	amlodipine (Norvasc)	amlodipine(Norvasc, Pfizer, USA) given once daily

Primary Outcome Measures

Name	Time	Method
flow-mediated dilation (FMD)	12-24 weeks	After 12-week maintenance treatment or at 24-week final visit.

Secondary Outcome Measures

Name	Time	Method
augmentation index (AIx)	12-24 weeks	After 12-week maintenance treatment or at 24-week final visit.
pulse wave velocity (cf-PWV, ba-PWV)	12-24 weeks	After 12-week maintenance treatment or at 24-week final visit.
liver function	6-24weeks	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.
ankle-brachial index (ABI)	12-24 weeks	After 12-week maintenance treatment or at 24-week final visit.
carotid intima-media thickness (IMT)	12-24 weeks	After 12-week maintenance treatment or at 24-week final visit.
cholesterol level	12-24 weeks	After 12-week maintenance treatment or at 24-week final visit.

Trial Locations

Locations (1)

Shanghai Institute of Hypertension; 🇨🇳 Shanghai, Shanghai, China