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Amlodipine Plus/Minus Atorvastatin for Protection of Arteries

S

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)

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)

Trial contacts and locations

1

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Central trial contact

Yan Yang

Data sourced from clinicaltrials.gov

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