NCT01520285

Brief Summary

This study will be compare Felodipine sustained-release tablets, to Lercanidipine hydrochloride tablets (Zanidip®) for the treatment of patients with mild-to-moderate primary hypertension and to investigate the influence on patients' heart rate and blood pressure variability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
281

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 13, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

October 16, 2014

Status Verified

October 1, 2014

Enrollment Period

1.2 years

First QC Date

January 13, 2012

Last Update Submit

October 14, 2014

Conditions

Hypertension

Keywords

hypertensionBlood pressure decreaseefficacy

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in mean seated diastolic blood pressure in clinical after 6 weeks of treatment

    after 6 weeks of treatment, the Changes from baseline in mean seated diastolic blood pressure in clinical will be compared between study drug and control drug

    6 weeks

Secondary Outcomes (1)

  • Change from baseline in mean seated systolic blood pressure after 6 weeks of treatment

    6 weeks

Study Arms (2)

Zanidip

ACTIVE COMPARATOR

tablets

Drug: Zanidip

Control Drug

PLACEBO COMPARATOR

Felodipine sustained-release tablet (5mg/tablet)

Drug: Felodipine sustained-release tablet

Interventions

ZanidipDRUG

Lercanidipine hydrochloride (10mg/tablet)once per day

Zanidip
Felodipine sustained-release tabletDRUG

Felodipine sustained-release tablet (5mg/tablet)

Control Drug

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Study population is patients with mild-to-moderate primary hypertension. The diagnosis of the patients should be in accordance with the diagnostic criteria in Chinese Guidelines for Hypertension Prevention and Treatment (2010). Patients meeting all of the following criteria are enrolled in the study:
  • Male or female patient, aged 18-75 years;
  • Mild-to-moderate primary hypertension;
  • mmHg ≤ DBP \< 110 mmHg and SBP \< 180mmHg;
  • Patient's 24h mean blood pressure (measuring by ABPM)\> 130/80mmHg;
  • Patient has signed informed consent form;

You may not qualify if:

  • Secondary hypertension;
  • Severe hypertension or other antihypertensive drugs unable to be discontinued;
  • History of heart failure or record of LVEF \< 40%, cardiomyopathy or valvular heart disease;
  • Severe arrhythmia, including arrhythmia, atrial fibrillation, atrial flutter, ventricular tachycardia, advanced atrioventricular block and sick sinus syndrome;
  • History of myocardial infarction or unstable angina during the past three months;
  • Type I diabetes;
  • Type II diabetes, fasting blood-glucose ≥ 11.1mmol/L;
  • ALT or AST ≥ 1.5 times the upper limit of the reference value;
  • Abnormal thyroid function (hyperthyroidism and hypothyroidism);
  • Acute or chronic renal insufficiency (serum creatinine of male patient \> 176.8 μmol/L and female patient \> 159.12μmol/L);
  • Patient suffers from anxiety or depression;
  • Mental disease or senile dementia;
  • Hypersensitivity to calcium channel blockers;
  • Pregnancy, lactation; women of child-bearing age use hormonal contraception, or perimenopause women receive hormone treatment;
  • History of drug or alcohol abuse within two years prior to enrollment;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai First People's Hospital

Shanghai, 200000, China

Location

Related Publications (1)

  • Xu M, Wu Y, Wang H, Xu X, Zhao S, Zhang M, Jin H, Yan J, Wang B, Gong J, Lu X, Peng J, Dai Q. Effects of lercanidipine hydrochloride versus felodipine sustained-release on day-to-day home blood pressure variability. Curr Med Res Opin. 2016 Oct;32(sup2):43-52. doi: 10.1080/03007995.2016.1220932.

    PMID: 27779454DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

lercanidipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2012

First Posted

January 27, 2012

Study Start

December 1, 2011

Primary Completion

March 1, 2013

Study Completion

August 1, 2013

Last Updated

October 16, 2014

Record last verified: 2014-10

Locations

CN(1)