HypertensionPhase 4NCT02641821
Effect of Nifedipine GITS in Patients With Mild-to-moderate Primary Hypertension
A Phase 4 study testing Nifedipine GITS in people with Hypertension, run by Peking University First Hospital at 1 site in China.
Trial summary
This is a multi-center, open-label, observational study. The aim of this study is to evaluate the efficacy of Nifedipine GITS on lowering blood pressure in Chinese adults with mild-to-moderate hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Nifedipine GITS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Dec 2019
- 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
- a seated systolic BP (SBP) ≥140 mmHg and <180 mmHg and/or a seated diastolic BP (DBP) ≥90 mmHg and <110 mmHg;
- an age ≥18 and ≤75 years;
- those who had not taken any BP-lowering medications in 1 month before the study.
Who cannot join
- a seated systolic BP (SBP) ≥180 mmHg and/or a seated diastolic BP ≥110 mmHg;
- secondary hypertension;
- diagnosed heart failure or stroke;
- Any of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was above 1.5 times of it's normal value upper limit, Serum creatinine >177 µmmol/L (2mg/dL), or liver cirrhosis;
- subjects with carotid stenosis or systolic murmur
- subjects with a history of unstable angina pectoris, acute mycardial infarction, percutaneous transluminal coronary angiography or coronary artery bypass grafting in the past 6 months;
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- subjects who were within lactation period, pregnant, or planning to become pregnant during the study;
- hypersensitive to Nifedipine GITS or with SAE;
- subjects who are participating in other clinical trials;
- considered not fit for the study due to other reasons according to the researchers (such as Malignant tumor, psyche or nervous system dysfunction, or special diseases).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Division of Cardiology, Peking University First Hospital
Beijing, 100034
Yang Yu, 8610-83575262, jiyou_2000@163.com
Yong Huo, MD
About this study
Official title: Effect of Nifedipine GITS in Patients With Mild-to-moderate Primary Hypertension: a Multi-center, Open-label, Observational Study
This is a multi-center, open-label, observational study. The aim of this study is to evaluate the efficacy of Nifedipine GITS on lowering blood pressure in Chinese adults with mild-to-moderate hypertension.
Read the detailed description
The primary aim of the study is to evaluate the efficacy of nifedipine gastrointestinal therapeutic system (GITS) on lowering blood pressure in Chinese adults with mild-to-moderate hypertension. The secondary aim of the study is to evaluate the efficacy of Nifedipine GITS on lowering blood pressure in hypertensive patients with different urinary sodium levels. Based on sample size estimation, the plan is to recruit 700 patients from 16 centers. At baseline, patients'demographic characters, disease history and anthropometric indices will be collected, laboratory tests will be performed for blood routine examination, urinalysis, renal function, hepatic function, urinary sodium and 24-hour urinary sodium. All eligible patients will be assigned to a treatment of Nifedipine GITS and followed up for 8 weeks. At 0 day, 2,weeks, 4 weeks and 8 weeks of the study, seated blood pressure, vital signs, medication and adverse events were collected. At the end of the study, 24-hour ambulatory blood pressure monitoring (ABPM) will be performed for all participants.
- Conditions
- Hypertension
- Being tested
- Nifedipine GITS
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine GITSDrug
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine GITS | Experimental | Not described Receives: Drug: Nifedipine GITS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control rate of hypertension evaluated by office blood pressure at 8 weeks
Measured: 8 weeks
Control rate of hypertension evaluated by office blood pressure at 4 weeks
Measured: 4 weeks
Control rate of hypertension evaluated by office blood pressure at 2 weeks
Measured: 2 weeks
Secondary outcomes (3)
Control rate of hypertension evaluated by 24-hour ABPM at 8 weeks
Measured: 8 weeks
Change of office blood pressure from baseline to 8 weeks
Measured: 8 weeks
Change of 24-hour ABPM from baseline to 8 weeks
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Yong Huo, Peking University First Hospital
- Investigators
- Yong Huo, MD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641821
- Sponsor's protocol ID
- Nifedipine-HT-1.0
- Status last verified
- Mar 2019
- First submitted
- 18 Dec 2015
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nifedipine GITS in Patients With Mild-to-moderate Primary Hypertension: a Multi-center, Open-label, Observational Study
- ClinicalTrials.gov ID
- NCT02641821
- Acronym / sponsor ID
- Nifedipine-HT-1.0
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Oct 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 29 Dec 2015 (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.
This is a multi-center, open-label, observational study. The aim of this study is to evaluate the efficacy of Nifedipine GITS on lowering blood pressure in Chinese adults with mild-to-moderate hypertension.
Detailed description
The primary aim of the study is to evaluate the efficacy of nifedipine gastrointestinal therapeutic system (GITS) on lowering blood pressure in Chinese adults with mild-to-moderate hypertension. The secondary aim of the study is to evaluate the efficacy of Nifedipine GITS on lowering blood pressure in hypertensive patients with different urinary sodium levels. Based on sample size estimation, the plan is to recruit 700 patients from 16 centers. At baseline, patients'demographic characters, disease history and anthropometric indices will be collected, laboratory tests will be performed for blood routine examination, urinalysis, renal function, hepatic function, urinary sodium and 24-hour urinary sodium. All eligible patients will be assigned to a treatment of Nifedipine GITS and followed up for 8 weeks. At 0 day, 2,weeks, 4 weeks and 8 weeks of the study, seated blood pressure, vital signs, medication and adverse events were collected. At the end of the study, 24-hour ambulatory blood pressure monitoring (ABPM) will be performed for all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nifedipine GITS | Experimental | Drug: Nifedipine GITS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a seated systolic BP (SBP) ≥140 mmHg and <180 mmHg and/or a seated diastolic BP (DBP) ≥90 mmHg and <110 mmHg;
- an age ≥18 and ≤75 years;
- those who had not taken any BP-lowering medications in 1 month before the study.
Key exclusion criteria (10 listed)
- a seated systolic BP (SBP) ≥180 mmHg and/or a seated diastolic BP ≥110 mmHg;
- secondary hypertension;
- diagnosed heart failure or stroke;
- Any of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was above 1.5 times of it's normal value upper limit, Serum creatinine >177 µmmol/L (2mg/dL), or liver cirrhosis;
- subjects with carotid stenosis or systolic murmur
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 GITS | Drug | Nifedipine GITS |
Primary outcome
Control rate of hypertension evaluated by office blood pressure at 8 weeks
Time frame: 8 weeks
Control rate of hypertension evaluated by office blood pressure at 4 weeks
Time frame: 4 weeks
Control rate of hypertension evaluated by office blood pressure at 2 weeks
Time frame: 2 weeks
3 secondary outcomes
Control rate of hypertension evaluated by 24-hour ABPM at 8 weeks
Time frame: 8 weeks
Change of office blood pressure from baseline to 8 weeks
Time frame: 8 weeks
Change of 24-hour ABPM from baseline to 8 weeks
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
Yong Huo, MD principal investigator
Peking University First Hospital
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 GITS in people with Hypertension, run by Peking University First Hospital 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 10 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: status not confirmed, as of the sponsor's last update on 22 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Yu, MD (8610-83575262, jiyou_2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control rate of hypertension evaluated by office blood pressure at 8 weeks (time frame: 8 weeks). The study lists 3 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 22 Mar 2019.