HypertensionPhase 4NCT02217852
Treatment of Hypertension in Tibetan Adult Population
A Phase 4 study testing Nitrendipine, Hydrochlorothiazide and Captopril,Hydrochlorothiazide in people with Hypertension, run by West China Hospital at 1 site in China.
Trial summary
Several surveys had revealed that Tibetan adults had high prevalence of hypertension. However, there was no research studying the antihypertensive effect of the known drugs in Tibetan. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Nitrendipine, Hydrochlorothiazide and Captopril,Hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Jul 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Tibetan, who have been living in the Tibetan Plateau since he/she was born.
- Consistent with diagnosed hypertension, blood pressure, for 1-3 grade.
- Aged 18-80 years old.
- To sign informed consent.
Who cannot join
- diagnosis of secondary hypertension
- Hypertensive emergencies and urgencies
- Malignant hypertension
- Bilateral renal artery stenosis, Chronic Kidney Disease（CKD）, serum creatinine> 133μmol / L.
- Suffering from congenital heart disease, rheumatic heart disease, hypertrophic cardiomyopathy, aortic stenosis.
- Occurred within the past 6 months who had a stroke or transient ischemic attack (TIA), unstable angina, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA).
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- clinical significance of arrhythmia
- Active liver disease, history of chronic persistent hepatitis, alanine aminotransferase（ALT）> upper limit of normal.
- Pregnancy, pregnancy or breast-feeding women to prepare.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Positive Drug Controlled Clinical Trials to Compare the Efficacy of Nitrendipine and Hydrochlorothiazide , Captopril Plus Hydrochlorothiazide and Beijing Hypotensive No.0 in Tibetan Hypertension
Several surveys had revealed that Tibetan adults had high prevalence of hypertension. However, there was no research studying the antihypertensive effect of the known drugs in Tibetan. The main arms of our study were to determine if the efficacy of lowing blood pressure and protecting target organ damage differs between nitrendipine and Hydrochlorothiazide in mild hypertension in Tibetan, and to determine if the efficacy of lowing blood pressure and protecting target organ damage differs between captopril plus Hydrochlorothiazide and Beijing hypotensive No.0 in moderate and severe Tibetan hypertension.
Read the detailed description
Several surveys had revealed that Tibetan adults had high blood pressure(BP)and prevalence of hypertension than other parts of China and were also higher than those in developed nations as well. For example, one study found that among Tibetan herdsmen 40 years and older, the prevalence of hypertension was 56% and the mean systolic blood pressure/diastolic blood pressure was 146.6/92.0mmHg. However, the rates of awareness, treatment, and control were dismally low.
The Tibetan have been living in the Tibetan Plateau. The special natural and social environment there，as well as ethnic ,may all be involved in the etiology of the high prevalence and effect the response to antihypertensive treatment. Nevertheless, few interventional studies have been done in Tibetan hypertensive patients. Therefore, the purpose of our study was to compare the blood pressure reduction between different antihypertensive drugs. Nitrendipine, hydrochlorothiazide, captopril and Beijing hypotensive No.0 (also named" compound hypotensive tablet") are selected, which are cheap and available in the Tibetan Plateau.
Nitrendipine, hydrochlorothiazide and captopril are the representatives of Dihydropyridines Calcium antagonists, diuretics, and angiotensin-converting enzyme inhibitors, respectively. They are all recommended as the first-line antihypertensive drug. Beijing hypotensive No.0 is produce by China Resources Double-crane Pharmaceutical company in China, and it is a fixed-dose combination containing reserpine 0.1mg, hydrochlorothiazide 12.5mg, dihydralazine sulfate 12.5mg, triamterene 12.5mg. Many studies conducted in China have demonstrated its efficacy and safety in lowing blood pressure.
After recruitment, participant will be grouped according to their BP. If BP<160/100mmHg, monotherapy is started. Patient is randomly assigned to receive nitrendipine 10mg bid or Hydrochlorothiazide 12.5mg qd. If BP≥160/100mmHg, Patient is randomly assigned to receive two drug combination therapy(captopril 25mg three times daily (tid) and Hydrochlorothiazide 12.5mg qd) or Beijing hypotensive No.0 one pile qd. During the following 12 months，each participant will take at least four visits at 1、3、6 and 12 months respectively. Goal BP for all participants was less than 140/90mmHg, achieved by titrating the assigned study drug and adding open-label agents when necessary. The maximum dosage is 20mg BID for nitrendipine, 25mg qd for Hydrochlorothiazide and 50mg tid for captopril. The dosage of Beijing hypotensive No.0 should not be added.
- Conditions
- Hypertension
- Being tested
- Nitrendipine, Hydrochlorothiazide, Captopril,Hydrochlorothiazide, Beijing hypotensive No.0
- Keywords
- hypertension, Tibetan, Nitrendipine, hydrochlorothiazide, captopril, Beijing hypotensive No.0
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitrendipineDrug
doses used range from 10-20mg po bid. Total duration would be until completion or study or medication intolerance.
HydrochlorothiazideDrug
doses used range from 12.5-25mg po qd. Total duration would be until completion or study or medication intolerance.
Captopril,HydrochlorothiazideDrug
doses used range from 25-50mg po tid for captopril and 12.5-25mg po qd for hydrochlorothiazide. Total duration would be until completion or study or medication intolerance.
Beijing hypotensive No.0Drug
Also called compound hypotensive tablet
1 pile po qd or less. Total duration would be until completion or study or medication intolerance.
| Study group | Role | What they receive |
|---|---|---|
| A1 nitrendipine | Experimental | this arm will include Tibetan patients with hypertension whose BP is higher than 140/90mmHg but lower than 160/100mmHg and nitrendipine will be added (dose range 10mg-20mg bid). Receives: Drug: Nitrendipine |
| A2 hydrochlorothiazide | Experimental | this arm will include Tibetan patients with hypertension whose BP is higher than 140/90mmHg but lower than 160/100mmHg and hydrochlorothiazide will be added (dose range 12.5mg-25mg) Receives: Drug: Hydrochlorothiazide |
| B1 captopril plus Hydrochlorothiazide | Experimental | this arm will include Tibetan patients with hypertension whose BP is higher than 160/100mmHg and captopril plus Hydrochlorothiazide will be added (dose range：captopril 25mg-50mg tid, Hydrochlorothiazide 12.5mg-25mg qd). Receives: Drug: Captopril,Hydrochlorothiazide |
| B2 Beijing hypotensive No.0 | Experimental | this arm will include Tibetan patients with hypertension whose BP is higher than 160/100mmHg and Beijing hypotensive will be added (dose range：Beijing hypotensive No.0 one pile qd or less ). Receives: Drug: Beijing hypotensive No.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Blood Pressure
Change of systolic blood pressure，diastolic blood pressure and mean arterial pressure from baseline to study end at 12 months.
Measured: 12 months
Secondary outcomes (1)
Change of target organ damage
Change of target organ damage(including estimated glomerular filtration rate, microalbuminuria, carotid intima-media thickness, arterial stiffness, left ventricular mass index) from baseline to study end at 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2016 (estimated)
- Study completionJul 2016 (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 West China 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoping Chen, West China Hospital
- Investigators
- Xiaoping Chen, MD, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217852
- Sponsor's protocol ID
- WestChinaH 20140701
- Status last verified
- Aug 2014
- First submitted
- 13 Aug 2014
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Positive Drug Controlled Clinical Trials to Compare the Efficacy of Nitrendipine and Hydrochlorothiazide , Captopril Plus Hydrochlorothiazide and Beijing Hypotensive No.0 in Tibetan Hypertension
- ClinicalTrials.gov ID
- NCT02217852
- Acronym / sponsor ID
- WestChinaH 20140701
- Conditions
- Hypertension
- Keywords
- hypertension, Tibetan, Nitrendipine, hydrochlorothiazide, captopril, Beijing hypotensive No.0
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 15 Aug 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.
Several surveys had revealed that Tibetan adults had high prevalence of hypertension. However, there was no research studying the antihypertensive effect of the known drugs in Tibetan. The main arms of our study were to determine if the efficacy of lowing blood pressure and protecting target organ damage differs between nitrendipine and Hydrochlorothiazide in mild hypertension in Tibetan, and to determine if the efficacy of lowing blood pressure and protecting target organ damage differs between captopril plus Hydrochlorothiazide and Beijing hypotensive No.0 in moderate and severe Tibetan hypertension.
Detailed description
Several surveys had revealed that Tibetan adults had high blood pressure(BP)and prevalence of hypertension than other parts of China and were also higher than those in developed nations as well. For example, one study found that among Tibetan herdsmen 40 years and older, the prevalence of hypertension was 56% and the mean systolic blood pressure/diastolic blood pressure was 146.6/92.0mmHg. However, the rates of awareness, treatment, and control were dismally low.
The Tibetan have been living in the Tibetan Plateau. The special natural and social environment there，as well as ethnic ,may all be involved in the etiology of the high prevalence and effect the response to antihypertensive treatment. Nevertheless, few interventional studies have been done in Tibetan hypertensive patients. Therefore, the purpose of our study was to compare the blood pressure reduction between different antihypertensive drugs. Nitrendipine, hydrochlorothiazide, captopril and Beijing hypotensive No.0 (also named" compound hypotensive tablet") are selected, which are cheap and available in the Tibetan Plateau.
Nitrendipine, hydrochlorothiazide and captopril are the representatives of Dihydropyridines Calcium antagonists, diuretics, and angiotensin-converting enzyme inhibitors, respectively. They are all recommended as the first-line antihypertensive drug. Beijing hypotensive No.0 is produce by China Resources Double-crane Pharmaceutical company in China, and it is a fixed-dose combination containing reserpine 0.1mg, hydrochlorothiazide 12.5mg, dihydralazine sulfate 12.5mg, triamterene 12.5mg. Many studies conducted in China have demonstrated its efficacy and safety in lowing blood pressure.
After recruitment, participant will be grouped according to their BP. If BP<160/100mmHg, monotherapy is started. Patient is randomly assigned to receive nitrendipine 10mg bid or Hydrochlorothiazide 12.5mg qd. If BP≥160/100mmHg, Patient is randomly assigned to receive two drug combination therapy(captopril 25mg three times daily (tid) and Hydrochlorothiazide 12.5mg qd) or Beijing hypotensive No.0 one pile qd. During the following 12 months，each participant will take at least four visits at 1、3、6 and 12 months respectively. Goal BP for all participants was less than 140/90mmHg, achieved by titrating the assigned study drug and adding open-label agents when necessary. The maximum dosage is 20mg BID for nitrendipine, 25mg qd for Hydrochlorothiazide and 50mg tid for captopril. The dosage of Beijing hypotensive No.0 should not be added.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1 nitrendipine | Experimental | Drug: Nitrendipinethis arm will include Tibetan patients with hypertension whose BP is higher than 140/90mmHg but lower than 160/100mmHg and nitrendipine will be added (dose range 10mg-20mg bid). |
| A2 hydrochlorothiazide | Experimental | Drug: Hydrochlorothiazidethis arm will include Tibetan patients with hypertension whose BP is higher than 140/90mmHg but lower than 160/100mmHg and hydrochlorothiazide will be added (dose range 12.5mg-25mg) |
| B1 captopril plus Hydrochlorothiazide | Experimental | Drug: Captopril,Hydrochlorothiazidethis arm will include Tibetan patients with hypertension whose BP is higher than 160/100mmHg and captopril plus Hydrochlorothiazide will be added (dose range：captopril 25mg-50mg tid, Hydrochlorothiazide 12.5mg-25mg qd). |
| B2 Beijing hypotensive No.0 | Experimental | Drug: Beijing hypotensive No.0this arm will include Tibetan patients with hypertension whose BP is higher than 160/100mmHg and Beijing hypotensive will be added (dose range：Beijing hypotensive No.0 one pile qd or less ). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult Tibetan, who have been living in the Tibetan Plateau since he/she was born.
- Consistent with diagnosed hypertension, blood pressure, for 1-3 grade.
- Aged 18-80 years old.
- To sign informed consent.
Key exclusion criteria (9 listed)
- diagnosis of secondary hypertension
- Hypertensive emergencies and urgencies
- Malignant hypertension
- Bilateral renal artery stenosis, Chronic Kidney Disease（CKD）, serum creatinine> 133μmol / L.
- Suffering from congenital heart disease, rheumatic heart disease, hypertrophic cardiomyopathy, aortic stenosis.
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 |
|---|---|---|
| Nitrendipinedoses used range from 10-20mg po bid. Total duration would be until completion or study or medication intolerance. | Drug | A1 nitrendipine |
| Hydrochlorothiazidedoses used range from 12.5-25mg po qd. Total duration would be until completion or study or medication intolerance. | Drug | A2 hydrochlorothiazide |
| Captopril,Hydrochlorothiazidedoses used range from 25-50mg po tid for captopril and 12.5-25mg po qd for hydrochlorothiazide. Total duration would be until completion or study or medication intolerance. | Drug | B1 captopril plus Hydrochlorothiazide |
| Beijing hypotensive No.0Also: compound hypotensive tablet1 pile po qd or less. Total duration would be until completion or study or medication intolerance. | Drug | B2 Beijing hypotensive No.0 |
Primary outcome
Change of Blood Pressure
Time frame: 12 months
Change of systolic blood pressure，diastolic blood pressure and mean arterial pressure from baseline to study end at 12 months.
1 secondary outcome
Change of target organ damage
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
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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.
Xiaoping Chen, MD principal investigator
West China 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 Nitrendipine, Hydrochlorothiazide and Captopril,Hydrochlorothiazide in people with Hypertension, run by West China 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 4 inclusion and 9 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 29 Aug 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. 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 Xiaoping Chen, MD (86-028-85422175, xiaopingchen11@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Blood Pressure (time frame: 12 months). 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 29 Aug 2014.