HypertensionPhase 4NARRASNCT02940548
Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness
A Phase 4 study testing Nifedipine GITS and Amlodipine besylate in people with Hypertension, run by Jing Liu at 1 site in China.
Trial summary
This trial evaluates the effects of Nifedipine GITS and Amlodipine besylate on blood pressure rhythm restoration and arterial stiffness in young and middle-aged non-dipper hypertensives. Half of participants will receive Nifedipine GITS, half of half will take medicine in the morning or at night. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Nifedipine GITS and Amlodipine besylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Dec 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate (Office blood pressure : 140 mmHg =< systolic blood pressure (SBP) <180 mmHg and / or 90 mmHg =< diastolic blood pressure (DBP) <110 mmHg) , non-dipper (ambulatory blood pressure monitoring (ABPM): night-time mean SBP / day-time mean SBP >=0.9 and night-time mean SBP >=120 mmHg) hypertensive subjects, who is drug treatment-naive or previously treated but discontinued for 2 weeks or more
- The subject is voluntary to participate in the study and has signed the informed consent form
Who cannot join
- Known allergy to any component of Nifedipine and Amlodipine
- Office SBP >=180 mmHg and / or DBP >=110 mmHg in the screening period
- The patient who is taking calcium antagonists (monotherapy or combination with other drugs)
- Evidences of secondary hypertension
- History of cerebrovascular events, cardiac failure, serious coronary artery disease within 12 months
- Type 1 diabetes mellitus (DM)
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- Severe liver diseases or renal insufficiency
- The pregnant woman, the woman who may be pregnant or plan to be pregnant, or the lactating woman
- The subject who needs to work at night (on night shift)
- Other reasons that the subject can not participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study for the Effects of Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness in the Young and Middle-aged Subjects With Non-dipper Hypertension
This trial evaluates the effects of Nifedipine GITS and Amlodipine besylate on blood pressure rhythm restoration and arterial stiffness in young and middle-aged non-dipper hypertensives. Half of participants will receive Nifedipine GITS, half of half will take medicine in the morning or at night. While the other half participants will take amlodipine besylate, whom will also be assigned taking medicine in the morning or at night. Ambulatory blood pressure monitoring and arterial stiffness examination will be performed before and after pharmaceutical intervention.
Read the detailed description
Written informed consent will obtained from all the participants. All the adverse reaction or adverse event, related or unrelated to the study drug, will be recorded in detail, including the occurrence time, symptoms and vital signs, degree, duration, laboratory test indexes, treatment methods and results, process, follow-up time, etc.
If serious adverse event occurs, study drugs should be stopped and necessary remedy should be delivered immediately. At the same time, the investigator must report it to the local drug supervision, medical ethics committee and China Food and Drug Administration.
-
- Conditions
- Hypertension
- Being tested
- Nifedipine GITS, Amlodipine besylate
- Keywords
- non-dipper hypertension, young, middle-aged, ambulatory blood pressure monitoring, arterial stiffness, nifedipine gastrointestinal therapeutic system (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
Also called Adalat
Nifedipine GITS 30~60mg/day for 8 weeks
Amlodipine besylateDrug
Also called Norvasc
Amlodipine besylate 5~10mg/day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine GITS | Active comparator | Nifedipine GITS 30~60mg/day Receives: Drug: Nifedipine GITS |
| Amlodipine besylate | Active comparator | Amlodipine besylate 5~10mg/day Receives: Drug: Amlodipine besylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nighttime systolic blood pressure reduction
Compare the effects of two active drugs on nighttime systolic blood pressure reduction
Measured: 8 weeks
Secondary outcomes (2)
The proportion of recovery of dipper rhythm of blood pressure
Compare the effects of two active drugs and different time administration on recovery of dipper rhythm. The proportion of blood pressure dipper rhythm at 8 weeks after two drugs administration will be calculated. The proportion of dipper rhythm at 8 weeks after two drugs administration in the morning or at night will also be calculated.
Measured: 8 weeks
Change of pulse wave velocity
Compare the effects of two active drugs on pulse wave velocity(PWV). PWV will be measured before and after 8 weeks two active drugs administration.
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 posted21 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2020
- Study completionDec 2020
Why it stopped: The patient recruitment and follow-ups were influenced with the pandemic of COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jing Liu
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor-investigator, Jing Liu, Peking University People's Hospital
- Investigators
- Jing Liu, M.D., Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940548
- Sponsor's protocol ID
- 2016PHB013-02
- Acronym
- NARRAS
- Status last verified
- Apr 2022
- First submitted
- 15 Oct 2016
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
de la Sierra A, Redon J, Banegas JR, Segura J, Parati G, Gorostidi M, de la Cruz JJ, Sobrino J, Llisterri JL, Alonso J, Vinyoles E, Pallares V, Sarria A, Aranda P, Ruilope LM; Spanish Society of Hypertension Ambulatory Blood Pressure Monitoring Registry Investigators. Prevalence and factors associated with circadian blood pressure patterns in hypertensive patients. Hypertension. 2009 Mar;53(3):466-72. doi: 10.1161/HYPERTENSIONAHA.108.124008. Epub 2009 Jan 26.
PubMed 19171788Liu J. A comparative study for the effects of nifedipine GITS and amlodipine besylate administrated in daytime or at nighttime on recovery of blood pressure rhythm and arterial stiffness in the young and middle-aged subjects with non-dipper hypertension (NARRAS): Design and rationale. Int J Clin Pract. 2020 Dec;74(12):e13628. doi: 10.1111/ijcp.13628. Epub 2020 Sep 3.
PubMed 32726499
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study for the Effects of Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness in the Young and Middle-aged Subjects With Non-dipper Hypertension
- ClinicalTrials.gov ID
- NCT02940548
- Acronym / sponsor ID
- NARRAS / 2016PHB013-02
- Conditions
- Hypertension
- Keywords
- non-dipper hypertension, young, middle-aged, ambulatory blood pressure monitoring, arterial stiffness, nifedipine gastrointestinal therapeutic system (GITS)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The patient recruitment and follow-ups were influenced with the pandemic of COVID-19
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Jing LiuUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 21 Oct 2016 (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 trial evaluates the effects of Nifedipine GITS and Amlodipine besylate on blood pressure rhythm restoration and arterial stiffness in young and middle-aged non-dipper hypertensives. Half of participants will receive Nifedipine GITS, half of half will take medicine in the morning or at night. While the other half participants will take amlodipine besylate, whom will also be assigned taking medicine in the morning or at night. Ambulatory blood pressure monitoring and arterial stiffness examination will be performed before and after pharmaceutical intervention.
Detailed description
Written informed consent will obtained from all the participants. All the adverse reaction or adverse event, related or unrelated to the study drug, will be recorded in detail, including the occurrence time, symptoms and vital signs, degree, duration, laboratory test indexes, treatment methods and results, process, follow-up time, etc.
If serious adverse event occurs, study drugs should be stopped and necessary remedy should be delivered immediately. At the same time, the investigator must report it to the local drug supervision, medical ethics committee and China Food and Drug Administration.
-
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nifedipine GITS | Active comparator | Drug: Nifedipine GITSNifedipine GITS 30~60mg/day |
| Amlodipine besylate | Active comparator | Drug: Amlodipine besylateAmlodipine besylate 5~10mg/day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mild to moderate (Office blood pressure : 140 mmHg =< systolic blood pressure (SBP) <180 mmHg and / or 90 mmHg =< diastolic blood pressure (DBP) <110 mmHg) , non-dipper (ambulatory blood pressure monitoring (ABPM): night-time mean SBP / day-time mean SBP >=0.9 and night-time mean SBP >=120 mmHg) hypertensive subjects, who is drug treatment-naive or previously treated but discontinued for 2 weeks or more
- The subject is voluntary to participate in the study and has signed the informed consent form
Key exclusion criteria (10 listed)
- Known allergy to any component of Nifedipine and Amlodipine
- Office SBP >=180 mmHg and / or DBP >=110 mmHg in the screening period
- The patient who is taking calcium antagonists (monotherapy or combination with other drugs)
- Evidences of secondary hypertension
- History of cerebrovascular events, cardiac failure, serious coronary artery disease within 12 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 |
|---|---|---|
| Nifedipine GITSAlso: AdalatNifedipine GITS 30~60mg/day for 8 weeks | Drug | Nifedipine GITS |
| Amlodipine besylateAlso: NorvascAmlodipine besylate 5~10mg/day for 8 weeks | Drug | Amlodipine besylate |
Primary outcome
Nighttime systolic blood pressure reduction
Time frame: 8 weeks
Compare the effects of two active drugs on nighttime systolic blood pressure reduction
2 secondary outcomes
The proportion of recovery of dipper rhythm of blood pressure
Time frame: 8 weeks
Change of pulse wave velocity
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: The patient recruitment and follow-ups were influenced with the pandemic of COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Background: PubMed 19171788de la Sierra A, Redon J, Banegas JR, Segura J, Parati G, Gorostidi M, de la Cruz JJ, Sobrino J, Llisterri JL, Alonso J, Vinyoles E, Pallares V, Sarria A, Aranda P, Ruilope LM; Spanish Society of Hypertension Ambulatory Blood Pressure Monitoring Registry Investigators. Prevalence and factors associated with circadian blood pressure patterns in hypertensive patients. Hypertension. 2009 Mar;53(3):466-72. doi: 10.1161/HYPERTENSIONAHA.108.124008. Epub 2009 Jan 26.
- Derived from this study: PubMed 32726499Liu J. A comparative study for the effects of nifedipine GITS and amlodipine besylate administrated in daytime or at nighttime on recovery of blood pressure rhythm and arterial stiffness in the young and middle-aged subjects with non-dipper hypertension (NARRAS): Design and rationale. Int J Clin Pract. 2020 Dec;74(12):e13628. doi: 10.1111/ijcp.13628. Epub 2020 Sep 3.
- 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.
Jing Liu, M.D. principal investigator
Peking University People's 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 and Amlodipine besylate in people with Hypertension, run by Jing Liu 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 2 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: stopped early, as of the sponsor's last update on 29 Apr 2022. 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 was stopped early (reason given: The patient recruitment and follow-ups were influenced with the pandemic of COVID-19). Results are not available in the source record.
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?
Nighttime systolic blood pressure reduction (time frame: 8 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 NCT02940548, which also lists 2 linked publications.
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 29 Apr 2022.