Compare the Effects of Lercanidipine Hydrochloride Tablet (Zanidip®) and Felodipine Sustained-Release Tablet for Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Zanidip; Felodipine sustained-release tablet
Intervention type(s): Drug; Drug
Intervention description(s): Lercanidipine hydrochloride (10mg/tablet)once per day; Felodipine sustained-release tablet (5mg/tablet)
Intervention MeSH terms: Felodipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension; Blood pressure decrease; efficacy