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Compare the Effects of Lercanidipine Hydrochloride Tablet (Zanidip®) and Felodipine Sustained-Release Tablet for Hypertension (Zanidip)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01520285
Recruitment Status : Completed
First Posted : January 27, 2012
Last Update Posted : October 16, 2014
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Zanidip Drug: Felodipine sustained-release tablet Phase 4

Detailed Description:

The study is designed as a multicenter, randomized, open-label, parallel-group and active controlled clinical study. The ratio of test group (lercanidipine group) and control group (felodipine group) is 1:1.

The study period lasts for 8 weeks, including 0-2 weeks of run-in period and 6 weeks of treatment period. There are 5 visits: run-in period (V1), baseline (V2), 2 weeks after treatment (V3), 4 weeks after treatment (V4) and 6 weeks after treatment (V5).

There are about 2 weeks for run-in period, the patients should start continuous recording the data of self-measuring blood pressure and heart rate for 1 week (at least 5days) before randomized in V2. Patients who under the antihypertensive treatment or have discontinued the antihypertensive treatment for less than 1 week need to discontinued the treatment for over 1week and start this trial; patients who never received any antihypertensive drug or patients who have discontinued the antihypertensive treatment for over one week will directly enter treatment period.

In V2, investigator should confirm the patient meet the inclusion/exclusion criteria, only the eligible patients will be divided groups by random, and the rest need to drop-out this trial. In that day of randomization, patients should take drug.

After the randomization, the patients will be given study drugs, and take take once-daily dose of the study drugs at 07:00-09:00 (except the day of visit). During the treatment, there will be a visit every 2 weeks, and in each visit the patients need to get the study drug for next two weeks, totally 3 times. In V3 and V4, if the patients' mean DBP ≥ 90 mm Hg, the doses will be doubled, twice a day (07:00- 09:00 in the morning and 16:00-18:00 in the afternoon), otherwise, the dosage do not change.

From the day beginning administration of the study drugs, patient should measure the BP and HR every day with the electronic sphygmomanometer after getting up in the morning and before going to bed. And patient records the data of blood pressure and heart rate in the record card. 2 to 3 minutes waiting for each measure and at least 12 significant date for consecutive 3 days. In every visit, investigator will collect the data of patient's self-measuring blood pressure, and give new recording forms for self-measuring blood pressure to the patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Open-label, Parallel-group Clinical Study to Compare the Effects of Lercanidipine Hydrochloride Tablet (Zanidip®) and Felodipine Sustained-Release Tablet for the Treatment of Patients With Mild-to-Moderate Hypertension
Study Start Date : December 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Felodipine

Arm Intervention/treatment
Active Comparator: Zanidip
Drug: Zanidip
Lercanidipine hydrochloride (10mg/tablet)once per day

Placebo Comparator: Control Drug
Felodipine sustained-release tablet (5mg/tablet)
Drug: Felodipine sustained-release tablet
Felodipine sustained-release tablet (5mg/tablet)

Primary Outcome Measures :
  1. Change from baseline in mean seated diastolic blood pressure in clinical after 6 weeks of treatment [ Time Frame: 6 weeks ]
    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

Secondary Outcome Measures :
  1. Change from baseline in mean seated systolic blood pressure after 6 weeks of treatment [ Time Frame: 6 weeks ]
    1. Change from baseline in mean seated systolic blood pressure after 6 weeks of treatment;
    2. Normalization rate

      • Normalization rate of clinical: defined as patients with a SBP<140mmHg and a DBP<90mmHg after 6 weeks of treatment.
      • Normalization rate of ABPM: defined as patients with mean BP < 130/80 mm Hg within 24 hours after 6 weeks of treatment.
      • Normalization rate of self-measurement: defined as patients with mean BP < 135/85 mm Hg within 1 week after 6 weeks of treatment.
    3. Analysis the heteromorphosis of BP and HR.
    4. Evaluate the total effective rate of clinical

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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:

  1. Male or female patient, aged 18-75 years;
  2. Mild-to-moderate primary hypertension;
  3. 90mmHg ≤ DBP < 110 mmHg and SBP < 180mmHg;
  4. Patient's 24h mean blood pressure (measuring by ABPM)> 130/80mmHg;
  5. Patient has signed informed consent form;

Exclusion Criteria:

  1. Secondary hypertension;
  2. Severe hypertension or other antihypertensive drugs unable to be discontinued;
  3. History of heart failure or record of LVEF < 40%, cardiomyopathy or valvular heart disease;
  4. Severe arrhythmia, including arrhythmia, atrial fibrillation, atrial flutter, ventricular tachycardia, advanced atrioventricular block and sick sinus syndrome;
  5. History of myocardial infarction or unstable angina during the past three months;
  6. Type I diabetes;
  7. Type II diabetes, fasting blood-glucose ≥ 11.1mmol/L;
  8. ALT or AST ≥ 1.5 times the upper limit of the reference value;
  9. Abnormal thyroid function (hyperthyroidism and hypothyroidism);
  10. Acute or chronic renal insufficiency (serum creatinine of male patient > 176.8 μmol/L and female patient > 159.12μmol/L);
  11. Patient suffers from anxiety or depression;
  12. Mental disease or senile dementia;
  13. Hypersensitivity to calcium channel blockers;
  14. Pregnancy, lactation; women of child-bearing age use hormonal contraception, or perimenopause women receive hormone treatment;
  15. History of drug or alcohol abuse within two years prior to enrollment;
  16. Concomitant administration of the following CYP3A4 strong inhibitors: ketoconazole, itraconazole, nefazodone, triacetyloleandomycin, clarithromycin, ritonavir, nelfinavir. Or other CYP3A4 inhibitors: erythromycin, verapamil, saquinavir, fluconazole; inducers of drugmetabolizing enzymes of liver (phenytoin, carbamazepine, rifampicin and barbiturates);
  17. Patient has suffered from cerebrovascular accident, severe trauma or undergone major operation;
  18. BMI ≥ 30 kg/m2;
  19. Participation in other clinical trials during the past three months;
  20. Investigator judged the patient unsuitable to participate in this trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01520285

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Shanghai First People's Hospital
Shanghai, China, 200000
Sponsors and Collaborators
Lee's Pharmaceutical Limited
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lee's Pharmaceutical Limited Identifier: NCT01520285    
Other Study ID Numbers: LEES_Zanidip_1
First Posted: January 27, 2012    Key Record Dates
Last Update Posted: October 16, 2014
Last Verified: October 2014
Keywords provided by Lee's Pharmaceutical Limited:
Blood pressure decrease
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents