Essential HypertensionPhase 4NCT02031861
Efficacy Study of Nifedipine Controlled-Release Tablets (Xin Ran) to Treat Mild to Moderate Essential Hypertension
A Phase 4 study testing nifedipine CR tablets (Xin Ran) and nifedipine CR tablets (Adalat) in people with Essential Hypertension, run by Shanghai Shyndec Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to compare nifedipine controlled-release (CR) tablets (Xin Ran) with nifedipine controlled-release tablets (Adalat）in the treatment of mild to moderate essential hypertension. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- nifedipine CR tablets (Xin Ran) and nifedipine CR tablets (Adalat)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Jul 2014
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate and must sign informed consent form
- Mild to moderate essential hypertension (SBP 140-179 mmHg and/or DBP 90-109 mmHg)
- Average DBP measured by 24-hour ambulatory blood pressure monitoring (ABPM) ≥80 mmHg
Who cannot join
- Secondary hypertension and malignant hypertension
- Pregnant or nursing women, or patients that cannot guarantee to take effective contraception measures
- Baseline SBP≥180 mmHg or DBP≥110 mmHg, or patients with cerebral, cardiac or renal complications
- Have following complications: cerebrovascular accident within 6 months, myocardial infarction or cardiac failure, macroaneurysm or dissecting aneurysm, definite angina, A-V block of grade 2 or higher, sick sinus syndrome, atrial fibrillation or other malignant arrhythmia
- Clinical significant diseases of heart, lung, liver, kidney and hematologic system or malignant tumors, HIV infection, uncontrolled diabetes (fasting blood glucose ≥7.0 mmol/L, 2-hour postprandial blood glucose ≥7.8 mmol/L)
- Kock pouch
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- Sever gastrointestinal stenosis
- Abnormal laboratory values with clinical significance, including serum potassium <3.5 or >5.5 mmol/L, glutamic-pyruvic transaminase (ALT) or glutamic oxalacetic transaminase (AST) >2-fold upper limit of normal (ULN), Cr >ULN
- Uric acid >ULN with the diagnosis of gout
- Gastrointestinal abnormalities or surgery that may interfere with drug absorption
- Hyperthyroidism or hypothyroidism
- Allergic to any ingredient or metabolite of investigational drug or drugs of similar structure
- Heavy smokers (>25 cigarettes every day), alcoholics (>250 ml liquor every day), drug addicts
- Psychological diseases, acrasia, cannot express explicitly
- Patients whose mood may be affected by variations in blood pressure, which in turn increases blood pressure
- Anxiety disorders, depression or cannot follow study protocol
- BMI >30
- Night shift, irregular sleep patterns or insomnia
- participate in other clinical trials within 3 months
- other conditions that investigators consider unsuitable for participation
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Random, Open Label, Active Comparator-controlled Parallel Study to Evaluate the Efficacy of Nifedipine Controlled-released Tablets (Xin Ran) in Patients With Mild to Moderate Essential Hypertension
The purpose of this study is to compare nifedipine controlled-release (CR) tablets (Xin Ran) with nifedipine controlled-release tablets (Adalat）in the treatment of mild to moderate essential hypertension.
- Conditions
- Essential Hypertension
- Being tested
- nifedipine CR tablets (Xin Ran), nifedipine CR tablets (Adalat)
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nifedipine CR tablets (Xin Ran)Drug
nifedipine CR tablets (Adalat)Drug
| Study group | Role | What they receive |
|---|---|---|
| nifedipine CR tablets (Xin Ran) | Experimental | Subjects will take a nifedipine controlled-release tablet (30 mg, Xin Ran) orally in every morning for a 12-week treatment period. Receives: Drug: nifedipine CR tablets (Xin Ran) |
| nifedipine CR tablets (Adalat) | Active comparator | Subjects will take a nifedipine controlled-release tablet (30 mg, Adalat) orally in every morning for a 12-week treatment period. Receives: Drug: nifedipine CR tablets (Adalat) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in morning blood pressure surge from baseline
Measured: 12 weeks
change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline
Measured: 12 weeks
Secondary outcomes (14)
change in morning blood pressure from baseline
Measured: 12 weeks
T/P ratio
Measured: 12 weeks
average reduction in systolic blood pressure from 18 to 24 hours after administration
Measured: 12 weeks
average reduction in diastolic blood pressure from 18 to 24 hours after administration
Measured: 12 weeks
smoothness index
Measured: 12 weeks
change in morning blood pressure surge from baseline
Measured: 8 weeks
change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline
Measured: 8 weeks
change in morning blood pressure from baseline
Measured: 8 weeks
T/P ratio
Measured: 8 weeks
average reduction in systolic blood pressure from 18 to 24 hours after administration
Measured: 8 weeks
average reduction in diastolic blood pressure from 18 to 24 hours after administration
Measured: 8 weeks
smoothness index
Measured: 8 weeks
change in systolic blood pressure (SBP) from baseline
Measured: 12 weeks
change in diastolic blood pressure (DBP) from baseline
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Shyndec Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pingjin Gao, Principal investigator, Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031861
- Sponsor's protocol ID
- CH-004PIV
- Status last verified
- Apr 2014
- First submitted
- 8 Jan 2014
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Random, Open Label, Active Comparator-controlled Parallel Study to Evaluate the Efficacy of Nifedipine Controlled-released Tablets (Xin Ran) in Patients With Mild to Moderate Essential Hypertension
- ClinicalTrials.gov ID
- NCT02031861
- Acronym / sponsor ID
- CH-004PIV
- Conditions
- Essential Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Shanghai Shyndec Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 Jan 2014 (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.
The purpose of this study is to compare nifedipine controlled-release (CR) tablets (Xin Ran) with nifedipine controlled-release tablets (Adalat）in the treatment of mild to moderate essential hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nifedipine CR tablets (Xin Ran) | Experimental | Drug: nifedipine CR tablets (Xin Ran)Subjects will take a nifedipine controlled-release tablet (30 mg, Xin Ran) orally in every morning for a 12-week treatment period. |
| nifedipine CR tablets (Adalat) | Active comparator | Drug: nifedipine CR tablets (Adalat)Subjects will take a nifedipine controlled-release tablet (30 mg, Adalat) orally in every morning for a 12-week treatment period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Voluntarily participate and must sign informed consent form
- Mild to moderate essential hypertension (SBP 140-179 mmHg and/or DBP 90-109 mmHg)
- Average DBP measured by 24-hour ambulatory blood pressure monitoring (ABPM) ≥80 mmHg
Key exclusion criteria (20 listed)
- Secondary hypertension and malignant hypertension
- Pregnant or nursing women, or patients that cannot guarantee to take effective contraception measures
- Baseline SBP≥180 mmHg or DBP≥110 mmHg, or patients with cerebral, cardiac or renal complications
- Have following complications: cerebrovascular accident within 6 months, myocardial infarction or cardiac failure, macroaneurysm or dissecting aneurysm, definite angina, A-V block of grade 2 or higher, sick sinus syndrome, atrial fibrillation or other malignant arrhythmia
- Clinical significant diseases of heart, lung, liver, kidney and hematologic system or malignant tumors, HIV infection, uncontrolled diabetes (fasting blood glucose ≥7.0 mmol/L, 2-hour postprandial blood glucose ≥7.8 mmol/L)
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 |
|---|---|---|
| nifedipine CR tablets (Xin Ran) | Drug | nifedipine CR tablets (Xin Ran) |
| nifedipine CR tablets (Adalat) | Drug | nifedipine CR tablets (Adalat) |
Primary outcome
change in morning blood pressure surge from baseline
Time frame: 12 weeks
change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline
Time frame: 12 weeks
14 secondary outcomes
change in morning blood pressure from baseline
Time frame: 12 weeks
T/P ratio
Time frame: 12 weeks
average reduction in systolic blood pressure from 18 to 24 hours after administration
Time frame: 12 weeks
average reduction in diastolic blood pressure from 18 to 24 hours after administration
Time frame: 12 weeks
smoothness index
Time frame: 12 weeks
change in morning blood pressure surge from baseline
Time frame: 8 weeks
change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline
Time frame: 8 weeks
change in morning blood pressure from baseline
Time frame: 8 weeks
T/P ratio
Time frame: 8 weeks
average reduction in systolic blood pressure from 18 to 24 hours after administration
Time frame: 8 weeks
average reduction in diastolic blood pressure from 18 to 24 hours after administration
Time frame: 8 weeks
smoothness index
Time frame: 8 weeks
change in systolic blood pressure (SBP) from baseline
Time frame: 12 weeks
change in diastolic blood pressure (DBP) from baseline
Time frame: 12 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 5 Feb 2015.
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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.
Pingjin Gao principal investigator
Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School
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 nifedipine CR tablets (Xin Ran) and nifedipine CR tablets (Adalat) in people with Essential Hypertension, run by Shanghai Shyndec Pharmaceutical Co., Ltd. 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 3 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 5 Feb 2015. 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. 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 in morning blood pressure surge from baseline (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2015.