A Phase 4 interventional study of Zanidip and Felodipine sustained-release tablet in Hypertension, sponsored by Lee's Pharmaceutical Limited. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-10-16.
Sponsored by Lee's Pharmaceutical Limited · Phase 4, Interventional, and Treatment
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.
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 281 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Lee's Pharmaceutical Limited is the lead sponsor of 73 studies on the registry; 6 are open to participants now.
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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:
Exclusion Criteria:
tablets
Drug: Zanidip
Felodipine sustained-release tablet (5mg/tablet)
Drug: Felodipine sustained-release tablet
Lercanidipine hydrochloride (10mg/tablet)once per day
Felodipine sustained-release tablet (5mg/tablet)
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
Time frame: 6 weeks
Change from baseline in mean seated systolic blood pressure after 6 weeks of treatment
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
Time frame: 6 weeks
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Lee's Pharmaceutical Limited