HypertensionPhase 2/3NCT02513927
The Effects of Nifedipine and Metoprolol on Blood Pressure Variability in Northern Chinese
A Phase 2/3 study testing metoprolol and Nifedipine in people with Hypertension, run by First Affiliated Hospital of Harbin Medical University at 1 site in Hungary.
Trial summary
Hypertension is one of the most common cardiovascular diseases, which is a major risk factor for stroke and cardiovascular events. Traditionally, cardiovascular risk stratification in hypertensive patients was based on the average blood pressure (BP) measured in the clinic. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- metoprolol and Nifedipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHungary
- Study dates
- Aug 2015to Oct 2018
- Phase
- Phase 2/3
- 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
- Men aged between 18 and 75 included years old
- Postmenopausal women who are no more than 75 years older.
- Patients with essential mild to moderate uncomplicated hypertension (DBP<110mmHg and SBP<180mmHg measured with a validated automatic device in sitting position) after initiation or intensification of appropriate healthy lifestyle modification,
- Without antihypertensive treatment in 2 weeks.
Who cannot join
- History of cerebrovascular disease: ischemic stroke, cerebral haemorrhage and TIA.
- History of cardiovascular disease:unstable angina, myocardial infarction, coronary revascularization and congestive heart failure.
- History of renal impairment.
- History of Type I diabetes mellitus or Type II diabetes uncontrolled.
- History of liver impairment.
- History of alcoholism or drug abuse.
- Known symptomatic orthostatic hypotension.
- Contra-indications to treatment with investigate products.
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Twenty-four-hour ambulatory BP monitoring
Budapest, Budapest
Jingyan Piao, MM, 86-451-85555333, 411483521@qq.com
Yujiao Pan, MM, 86-451-85555671, panyujiao@163.com
About this study
Official title: The Effects of Nifedipine and Metoprolol on Blood Pressure Variability in Northern Chinese: a Randomized Crossover Study
Hypertension is one of the most common cardiovascular diseases, which is a major risk factor for stroke and cardiovascular events. Traditionally, cardiovascular risk stratification in hypertensive patients was based on the average blood pressure (BP) measured in the clinic. Accumulated data has shown that target-organ damage is related not only to 24-h mean intra-arterial BP, but also to BP variability (BPV) in subjects with essential hypertension. Growing evidence demonstrated that BPV has considerable prognostic value for all-cause mortality and cardiovascular outcomes, independent of average BP.
At present, the normal range of BPV is not very clear. There are many studies about the effects of different kinds of drugs on blood pressure, but the clinical researches about the impacts of antihypertensive drugs on BPV are limited, and the conclusion is still controversial.
Read the detailed description
Hypertension is one of the most common cardiovascular diseases, which is a major risk factor for stroke and cardiovascular events. Traditionally, cardiovascular risk stratification in hypertensive patients was based on the average blood pressure (BP) measured in the clinic. Accumulated data has shown that target-organ damage is related not only to 24-h mean intra-arterial BP, but also to BP variability (BPV) in subjects with essential hypertension. Growing evidence demonstrated that BPV has considerable prognostic value for all-cause mortality and cardiovascular outcomes, independent of average BP.
The hypertension prevalences in the high latitude and cold regions are much higher than those in the low latitude and warm regions. In China, the prevalences of hypertension are gradually increased from the South to the North. Heilongjiang province is the "high-risk" region for hypertension, with a prevalence of 30.48%. This may be due to the combined effects of lower average temperature and higher intake of salt and saturated fatty acid, which Increased sympathetic nerve excitability, and eventually lead to elevation of blood pressure. Therefore, it is essential to formulate the best treatment of hypertension according with the physical characteristics of northern Chinese.
At present, the normal range of BPV is not very clear. There are many studies about the effects of different kinds of drugs on blood pressure, but the clinical researches about the impacts of antihypertensive drugs on BPV are limited, and the conclusion is still controversial.
- Conditions
- Hypertension
- Being tested
- metoprolol, Nifedipine
- Keywords
- Blood pressure variability, CCB, beta-receptor blockers, heart rate
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metoprololDrug
Metoprolol was given orally in a dose of 95 mg/day to treat patients in the metoprolol group for 12 weeks.
NifedipineDrug
Nifedipine was given orally in a dose of 30 mg/day to treat patients in the amlodipine group for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | To observe the effects of metoprolol (95 mg) on blood pressure variation after 12 weeks of treatment.Then to observe the effects of Nifedipine (30 mg) on blood pressure variation after 12 weeks of treatment. Receives: Drug: metoprolol; Drug: Nifedipine |
| B | Active comparator | To observe the effects of Nifedipine (30 mg) on blood pressure variation after 12 weeks of treatment. Then to observe the effects of metoprolol (95 mg) on blood pressure variation after 12 weeks of treatment. Receives: Drug: metoprolol; Drug: Nifedipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour Ambulatory Blood Pressure Monitoring
Measured: 3 years
Secondary outcomes (1)
plasma uric acid level
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2017 (estimated)
- Study completionOct 2018 (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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513927
- Sponsor's protocol ID
- HT-2
- Status last verified
- Sep 2015
- First submitted
- 21 Jul 2015
- Last updated
- 30 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Nifedipine and Metoprolol on Blood Pressure Variability in Northern Chinese: a Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT02513927
- Acronym / sponsor ID
- HT-2
- Conditions
- Hypertension
- Keywords
- Blood pressure variability, CCB, beta-receptor blockers, heart rate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 3 Aug 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.
Hypertension is one of the most common cardiovascular diseases, which is a major risk factor for stroke and cardiovascular events. Traditionally, cardiovascular risk stratification in hypertensive patients was based on the average blood pressure (BP) measured in the clinic. Accumulated data has shown that target-organ damage is related not only to 24-h mean intra-arterial BP, but also to BP variability (BPV) in subjects with essential hypertension. Growing evidence demonstrated that BPV has considerable prognostic value for all-cause mortality and cardiovascular outcomes, independent of average BP.
At present, the normal range of BPV is not very clear. There are many studies about the effects of different kinds of drugs on blood pressure, but the clinical researches about the impacts of antihypertensive drugs on BPV are limited, and the conclusion is still controversial.
Detailed description
Hypertension is one of the most common cardiovascular diseases, which is a major risk factor for stroke and cardiovascular events. Traditionally, cardiovascular risk stratification in hypertensive patients was based on the average blood pressure (BP) measured in the clinic. Accumulated data has shown that target-organ damage is related not only to 24-h mean intra-arterial BP, but also to BP variability (BPV) in subjects with essential hypertension. Growing evidence demonstrated that BPV has considerable prognostic value for all-cause mortality and cardiovascular outcomes, independent of average BP.
The hypertension prevalences in the high latitude and cold regions are much higher than those in the low latitude and warm regions. In China, the prevalences of hypertension are gradually increased from the South to the North. Heilongjiang province is the "high-risk" region for hypertension, with a prevalence of 30.48%. This may be due to the combined effects of lower average temperature and higher intake of salt and saturated fatty acid, which Increased sympathetic nerve excitability, and eventually lead to elevation of blood pressure. Therefore, it is essential to formulate the best treatment of hypertension according with the physical characteristics of northern Chinese.
At present, the normal range of BPV is not very clear. There are many studies about the effects of different kinds of drugs on blood pressure, but the clinical researches about the impacts of antihypertensive drugs on BPV are limited, and the conclusion is still controversial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: metoprolol, Drug: NifedipineTo observe the effects of metoprolol (95 mg) on blood pressure variation after 12 weeks of treatment.Then to observe the effects of Nifedipine (30 mg) on blood pressure variation after 12 weeks of treatment. |
| B | Active comparator | Drug: metoprolol, Drug: NifedipineTo observe the effects of Nifedipine (30 mg) on blood pressure variation after 12 weeks of treatment. Then to observe the effects of metoprolol (95 mg) on blood pressure variation after 12 weeks of treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men aged between 18 and 75 included years old
- Postmenopausal women who are no more than 75 years older.
- Patients with essential mild to moderate uncomplicated hypertension (DBP<110mmHg and SBP<180mmHg measured with a validated automatic device in sitting position) after initiation or intensification of appropriate healthy lifestyle modification,
- Without antihypertensive treatment in 2 weeks.
Key exclusion criteria (8 listed)
- History of cerebrovascular disease: ischemic stroke, cerebral haemorrhage and TIA.
- History of cardiovascular disease:unstable angina, myocardial infarction, coronary revascularization and congestive heart failure.
- History of renal impairment.
- History of Type I diabetes mellitus or Type II diabetes uncontrolled.
- History of liver impairment.
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 |
|---|---|---|
| metoprololMetoprolol was given orally in a dose of 95 mg/day to treat patients in the metoprolol group for 12 weeks. | Drug | A, B |
| NifedipineNifedipine was given orally in a dose of 30 mg/day to treat patients in the amlodipine group for 12 weeks. | Drug | A, B |
Primary outcome
24-hour Ambulatory Blood Pressure Monitoring
Time frame: 3 years
1 secondary outcome
plasma uric acid level
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing metoprolol and Nifedipine in people with Hypertension, run by First Affiliated Hospital of Harbin Medical University at 1 site in Hungary.
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 4 inclusion and 8 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 30 Sep 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 Hungary. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yue Li, PHD (86-451-85555673, ly99ly@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour Ambulatory Blood Pressure Monitoring (time frame: 3 years). 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 30 Sep 2015.