HypertensionPhase 4ZanidipNCT01520285

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

A Phase 4 study testing Zanidip and Felodipine sustained-release tablet in people with Hypertension, run by Lee's Pharmaceutical Limited at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hypertension
What is being tested?: Zanidip and Felodipine sustained-release tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 281 participants
Where: 1 siteChina
Study dates: Dec 2011to Aug 2013
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;
90mmHg ≤ DBP < 110 mmHg and SBP < 180mmHg;
Patient's 24h mean blood pressure (measuring by ABPM)> 130/80mmHg;
Patient has signed informed consent form;

Who cannot join

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;

Show all 20Show fewer

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;
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);
Patient has suffered from cerebrovascular accident, severe trauma or undergone major operation;
BMI ≥ 30 kg/m2;
Participation in other clinical trials during the past three months;
Investigator judged the patient unsuitable to participate in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai First People's Hospital
Shanghai, 200000

Other trials in China

About this study

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

Read the 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.

Conditions: Hypertension
Being tested: Zanidip, Felodipine sustained-release tablet
Keywords: hypertension, Blood pressure decrease, efficacy
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZanidipDrug
Lercanidipine hydrochloride (10mg/tablet)once per day
Felodipine sustained-release tabletDrug
Felodipine sustained-release tablet (5mg/tablet)

Study groups in NCT01520285
Study group	Role	What they receive
Zanidip	Active comparator	tablets Receives: Drug: Zanidip
Control Drug	Placebo comparator	Felodipine sustained-release tablet (5mg/tablet) Receives: Drug: Felodipine sustained-release tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 6 weeks

Secondary outcomes (1)

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.
1. Analysis the heteromorphosis of BP and HR.
2. Evaluate the total effective rate of clinical
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Aug 2013

First posted27 Jan 2012 (estimated)
Study startDec 2011
Primary completionMar 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 281 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01520285
Sponsor's protocol ID: LEES_Zanidip_1
Acronym: Zanidip
Status last verified: Oct 2014
First submitted: 13 Jan 2012
Last updated: 16 Oct 2014
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 27779454

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01520285
Acronym / sponsor ID: Zanidip / LEES_Zanidip_1
Conditions: Hypertension
Keywords: hypertension, Blood pressure decrease, efficacy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 281 participants (actual)
Lead sponsor: Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Mar 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 27 Jan 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Zanidip	Active comparator	Drug: Zanidiptablets
Control Drug	Placebo comparator	Drug: Felodipine sustained-release tabletFelodipine sustained-release tablet (5mg/tablet)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;
90mmHg ≤ DBP < 110 mmHg and SBP < 180mmHg;
Patient's 24h mean blood pressure (measuring by ABPM)> 130/80mmHg;

Key exclusion criteria (20 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ZanidipLercanidipine hydrochloride (10mg/tablet)once per day	Drug	Zanidip
Felodipine sustained-release tabletFelodipine sustained-release tablet (5mg/tablet)	Drug	Control Drug

Primary outcome

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

1 secondary outcome

Change from baseline in mean seated systolic blood pressure after 6 weeks of treatment
Time frame: 6 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.
Derived from this study: PubMed 27779454Xu 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.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Zanidip and Felodipine sustained-release tablet in people with Hypertension, run by Lee's Pharmaceutical Limited at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in mean seated diastolic blood pressure in clinical after 6 weeks of treatment (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01520285, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2014.