Amlodipine Plus/Minus Atorvastatin for Protection of Arteries

NCT ID: NCT01922687

Last Updated: 2013-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-12-31

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.

Conditions

Arterial and Arteriolar Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Amlodipine Plus Atorvastatin (Caduet)

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

Group Type: EXPERIMENTAL

amlodipine plus atorvastatin (Caduet)

Intervention Type: DRUG

Amlodipine (Norvasc)

amlodipine(Norvasc, Pfizer, USA) given once daily

Group Type: ACTIVE_COMPARATOR

amlodipine (Norvasc)

Intervention Type: DRUG

Interventions

amlodipine plus atorvastatin (Caduet)

Intervention Type: DRUG

amlodipine (Norvasc)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Institute of Hypertension

OTHER

Sponsor Role: lead

Responsible Party

Yan Yang

Attending physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Institute of Hypertension

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yan Yang

Role: CONTACT

Phone: 64370045

Email: jesuisyang@163.com

Facility Contacts

Pingjin Gao

Role: primary

References

Pingjin Gao

Reference Type: BACKGROUND

Other Identifiers

Ruijin2010No.14

Identifier Type: -

Identifier Source: org_study_id