NCT01922687

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
109

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 14, 2013

Status Verified

August 1, 2013

Enrollment Period

2.9 years

First QC Date

July 30, 2013

Last Update Submit

August 12, 2013

Conditions

Arterial and Arteriolar Disorders

Outcome Measures

Primary Outcomes (1)

  • flow-mediated dilation (FMD)

    After 12-week maintenance treatment or at 24-week final visit.

    12-24 weeks

Secondary Outcomes (6)

  • pulse wave velocity (cf-PWV, ba-PWV)

    12-24 weeks

  • liver function

    6-24weeks

  • ankle-brachial index (ABI)

    12-24 weeks

  • augmentation index (AIx)

    12-24 weeks

  • carotid intima-media thickness (IMT)

    12-24 weeks

  • +1 more secondary outcomes

Study Arms (2)

Amlodipine Plus Atorvastatin (Caduet)

EXPERIMENTAL

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

Drug: amlodipine plus atorvastatin (Caduet)

Amlodipine (Norvasc)

ACTIVE COMPARATOR

amlodipine(Norvasc, Pfizer, USA) given once daily

Drug: amlodipine (Norvasc)

Interventions

amlodipine plus atorvastatin (Caduet)DRUG
Amlodipine Plus Atorvastatin (Caduet)
amlodipine (Norvasc)DRUG
Amlodipine (Norvasc)

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women or men, aged from 40 to 75 years;
  • Women with child-bearing potential should apply an adequate non-pharmacological contraceptive technique;
  • 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.
  • The 24 h ambulatory blood pressure should be at least 130 mm Hg systolic or 80 mm Hg diastolic, or higher;
  • Fasting total cholesterol concentration ranging from 4.14 to 6.22 mmol/L (160 to 240 mg/dL);
  • Endothelium-dependent flow-mediated dilatation (FMD) below 10%;
  • Serum activity of aspartate aminotransferase (AST), alanine aminotransferase (ALT), and creatine kinase (CK) should be within the normal range;
  • Patients should not be on treatment with statins or other lipid-lowering drugs within 3 months of randomization;
  • The patients should sign the informed consent form prior to the participation in the trial at the first visit;
  • Patients should be independent and likely to adhere to the study protocol.

You may not qualify if:

  • Secondary hypertension;
  • Low-density lipoprotein cholesterol (LDL-C) below 2.59 mmol/L (100mg/dL);
  • Renal dysfunction defined as eGFR\<60ml/min/1.73m2;
  • Current treatment with specific drugs or diets, such as fibrates (especially gemfibrozil), verapamil, amiodarone, grapefruit juice;
  • Excessive alcohol consumption defined as drinking more than 1L/day;
  • Stroke within 2 years of randomization or myocardial infarction occurred previous;
  • Known contra-indications to a dihydropyridine calcium channel blocker or statins;
  • Any life threatening condition;
  • Current participation in another trial or trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Institute of Hypertension

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (1)

  • Pingjin Gao

    BACKGROUND

MeSH Terms

Interventions

AmlodipineAtorvastatinamlodipine, atorvastatin drug combination

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolesAzolesHeptanoic AcidsFatty AcidsLipids

Central Study Contacts

Yan Yang

CONTACT

64370045jesuisyang@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

July 30, 2013

First Posted

August 14, 2013

Study Start

April 1, 2011

Primary Completion

March 1, 2014

Study Completion

December 1, 2014

Last Updated

August 14, 2013

Record last verified: 2013-08

Locations

CN(1)