HypertensionNCT02255253
Telmisartan and Hydrochlorothiazide Antihypertensive Treatment Study in High Sodium Intake Population
A study testing Telmisartan and Hydrochlorothiazide in people with Hypertension, run by The George Institute for Global Health, China at 14 sites in China.
Trial summary
In this research, the investigators aim to compare the antihypertensive efficacy and safety of monotherapy of routine dose angiotensin receptor antagonist telmisartan (ARB) and diuretic Hydrochlorothiazide (HCTZ) in high sodium intake patients with mild to moderate hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Telmisartan and Hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,410 participants
- Where
- 14 sitesChina
- Study dates
- Oct 2014to Mar 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18
- Essential hypertension: systolic blood pressure (SBP) is between 140mmHg-179mmHg and diastolic blood pressure (DBP)<110mmHg OR DBP is between 90mmHg-109mmHg and SBP<180mmHg.
- Hypertension patients diagnosed by spot urine test (urine sodium≥200mmol/24h).
- Subjects are not using antihypertensive medicines or medicines which affect the blood pressure within a week.
- Subjects volunteer to be brought in the research and have signed informed consent form, given that they have understood the research content.
Who cannot join
- Females who are already pregnant, in lactation and intend to be pregnant.
- Patients who have seriously allergic reaction or angioneurotic edema when taking ARB; Patients who have allergic history of thiazide diuretic (HCTZ) or sulfonamides.
- Patients who do not want to stop or have to take the medicines which are also antihypertensive or affect the blood pressure, other than which provided by the research.
- Stroke or CHD patients who are diagnosed within 6 months. CHD patients are identified by being diagnosed by coronary arteriography or coronary CT angiography, having received coronary stent or coronary artery bypass surgery, or being diagnosed with acute myocardial infarction. Stroke patients are identified by being diagnosed with cerebral thrombosis, cerebral embolism, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack.
- Patients who are clearly diagnosed with following diseases: Congenital disease, myocardiopathy, serious arrhythmia, pulmonary heart disease, various of cardiac failure.
- Patients who are clearly diagnosed with following symptoms or diseases: Proteinuria or heavy proteinuria, renal insufficiency or serious renal function damage, hepatic insufficiency or serious hepatic function damage; retinal exudates or hemorrhage, or papilledema.
Show all 10Show fewer
- Patients who are clearly diagnosed with serious or deadly diseases in other systems.
- Patients who get dementia or other serious diseases cannot cooperate with researchers.
- Patients who drink 200g white spirits per day in past week.
- Patients who meet other situations which are considered to be inappropriate to be enrolled into the study by researchers.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
Chinese Traditional Medicine Hospital of Anguo
Baoding, Hebei, 071200
Boye hospital
Baoding, Hebei, 071300
Lixian chinese traditional medicine hospital
Baoding, Hebei, 071400
Gaoyang hospital
Baoding, Hebei, 071500
People's hospital in Rongcheng
Baoding, Hebei, 071700
Mancheng Hospital
Baoding, Hebei, 072150
Shunping Hospital
Baoding, Hebei, 072250
People's hospital of Tangxian
Baoding, Hebei, 072350
Wangdu hospital
Baoding, Hebei, 072450
Gaobeidian hospital
Baoding, Hebei, 074000
Central hospital in Baigou
Baoding, Hebei, 074004
The second hospital of Lai Shui
Baoding, Hebei, 074100
Wenan Hospital
Lanfang, Hebei, 065800
Dacheng chinese traditional medicine hospital
Langfang, Hebei, 065900
About this study
Official title: Efficacy of Telmisartan 40mg and Hydrochlorothiazide 25mg Monotherapy in High Sodium Intake Patients With Mild to Moderate Hypertension: a Multicenter Randomized Double-blinded Parallel Controlled Trial
In this research, the investigators aim to compare the antihypertensive efficacy and safety of monotherapy of routine dose angiotensin receptor antagonist telmisartan (ARB) and diuretic Hydrochlorothiazide (HCTZ) in high sodium intake patients with mild to moderate hypertension. The research will be conducted in the rural area in Hebei province, where people have a high sodium diet in their daily life. The 1200 eligible subjects will be drawn from 12 local county-level hospitals. Subjects will be randomly allocated in double-blind manner into ARB or HCTZ group to be administered telmisartan 40mg per day or hydrochlorothiazide 25mg per day respectively. After two-month treatment, the investigators will evaluate and compare the antihypertensive efficacy and safety between the two therapies.
The first objective of the research is to compare the antihypertensive efficacy of monotherapy of routine dose of angiotensin receptor antagonist telmisartan (ARB) and diuretic Hydrochlorothiazide (HCTZ) in high sodium intake patients with mild to moderate hypertension.The second objective is to compare the safety between the two therapies applied.
Read more
Null Hypothesis-H0: There will be no efficacy differences of lowering the systolic pressure between treating high sodium intake patients with mild to moderate hypertension with telmisartan and hydrochlorothiazide.Alternative Hypothesis-H1: There will be efficacy differences of lowering the systolic pressure between treating high sodium intake patients with mild to moderate hypertension with telmisartan and hydrochlorothiazide.
This research is a multicenter randomized double-blinded parallel controlled trial targeting on high sodium intake patients with mild to moderate hypertension in China. The eligible 1200 subjects will be randomly divided into ARB and HCTZ two groups, treated with monotherapy of telmisartan 40mg per day or hydrochlorothiazide 25mg per day respectively. Then, the compliance of the patients will be followed after a week. The investigators will evaluate the efficacy of blood pressure control and the safety of the medicines after one month and two months of the beginning of therapies. Figure 1 shows the research process.
- Conditions
- Hypertension
- Being tested
- Telmisartan, Hydrochlorothiazide
- Keywords
- Telmisartan, Hydrochlorothiazide, Efficacy, hypertension, high sodium intake
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
Also called China Resources Double-crane Pharmaceutical Co., Ltd
capsule,40mg per day,2 months
HydrochlorothiazideDrug
Also called Tianjin LiSheng Pharmaceutical Co., Ltd
tablet, 25mg per day, 2 months
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan | Experimental | capsule,40mg per day,2 months Receives: Drug: Telmisartan |
| Hydrochlorothiazide | Experimental | tablet, 25mg per day, 2 months Receives: Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between 2 groups of the decrease ranges of SBPs before and after the intervention of the subjects
We will measure the SBP for all the participants( around 1400) at baseline and 2\4\8 weeks after intervention with Omron electronic sphygmomanometer HBP - 1300. We will compare the differences between 2 groups at all 4 time points.
Measured: 2 months
Secondary outcomes (1)
The between-group difference of the decrease ranges of DBPs before and after the intervention of the subjects
We will measure the DBP for all the participants( around 1400) at baseline and 2\4\8 weeks after intervention with Omron electronic sphygmomanometer HBP - 1300. We will compare the differences between 2 groups at all 4 time points.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,410 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute for Global Health, China
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University People's Hospital
- Responsible party
- Principal investigator, Puhong Zhang, The George Institute for Global Health, China
- Investigators
- Zhang Pu Hong, Principal investigator, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255253
- Sponsor's protocol ID
- 2013BAI05B02
- Status last verified
- Mar 2015
- First submitted
- 24 Sep 2014
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang P, Wang H, Sun L, Zhang J, Xi Y, Wu Y, Yan LL, Li X, Sun N. Telmisartan and hydrochlorothiazide antihypertensive treatment in high sodium intake population: a randomized double-blind trial. J Hypertens. 2017 Oct;35(10):2077-2085. doi: 10.1097/HJH.0000000000001407.
PubMed 28509725
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Telmisartan 40mg and Hydrochlorothiazide 25mg Monotherapy in High Sodium Intake Patients With Mild to Moderate Hypertension: a Multicenter Randomized Double-blinded Parallel Controlled Trial
- ClinicalTrials.gov ID
- NCT02255253
- Acronym / sponsor ID
- 2013BAI05B02
- Conditions
- Hypertension
- Keywords
- Telmisartan, Hydrochlorothiazide, Efficacy, hypertension, high sodium intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,410 participants (actual)
- Lead sponsor
- The George Institute for Global Health, ChinaUniversity, hospital or other
- Collaborators
- Peking University People's Hospital
- Study start
- Oct 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 2 Oct 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.
In this research, the investigators aim to compare the antihypertensive efficacy and safety of monotherapy of routine dose angiotensin receptor antagonist telmisartan (ARB) and diuretic Hydrochlorothiazide (HCTZ) in high sodium intake patients with mild to moderate hypertension. The research will be conducted in the rural area in Hebei province, where people have a high sodium diet in their daily life. The 1200 eligible subjects will be drawn from 12 local county-level hospitals. Subjects will be randomly allocated in double-blind manner into ARB or HCTZ group to be administered telmisartan 40mg per day or hydrochlorothiazide 25mg per day respectively. After two-month treatment, the investigators will evaluate and compare the antihypertensive efficacy and safety between the two therapies.
The first objective of the research is to compare the antihypertensive efficacy of monotherapy of routine dose of angiotensin receptor antagonist telmisartan (ARB) and diuretic Hydrochlorothiazide (HCTZ) in high sodium intake patients with mild to moderate hypertension.The second objective is to compare the safety between the two therapies applied.
Null Hypothesis-H0: There will be no efficacy differences of lowering the systolic pressure between treating high sodium intake patients with mild to moderate hypertension with telmisartan and hydrochlorothiazide.Alternative Hypothesis-H1: There will be efficacy differences of lowering the systolic pressure between treating high sodium intake patients with mild to moderate hypertension with telmisartan and hydrochlorothiazide.
This research is a multicenter randomized double-blinded parallel controlled trial targeting on high sodium intake patients with mild to moderate hypertension in China. The eligible 1200 subjects will be randomly divided into ARB and HCTZ two groups, treated with monotherapy of telmisartan 40mg per day or hydrochlorothiazide 25mg per day respectively. Then, the compliance of the patients will be followed after a week. The investigators will evaluate the efficacy of blood pressure control and the safety of the medicines after one month and two months of the beginning of therapies. Figure 1 shows the research process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan | Experimental | Drug: Telmisartancapsule,40mg per day,2 months |
| Hydrochlorothiazide | Experimental | Drug: Hydrochlorothiazidetablet, 25mg per day, 2 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age≥18
- Essential hypertension: systolic blood pressure (SBP) is between 140mmHg-179mmHg and diastolic blood pressure (DBP)<110mmHg OR DBP is between 90mmHg-109mmHg and SBP<180mmHg.
- Hypertension patients diagnosed by spot urine test (urine sodium≥200mmol/24h).
- Subjects are not using antihypertensive medicines or medicines which affect the blood pressure within a week.
- Subjects volunteer to be brought in the research and have signed informed consent form, given that they have understood the research content.
Key exclusion criteria (10 listed)
- Females who are already pregnant, in lactation and intend to be pregnant.
- Patients who have seriously allergic reaction or angioneurotic edema when taking ARB; Patients who have allergic history of thiazide diuretic (HCTZ) or sulfonamides.
- Patients who do not want to stop or have to take the medicines which are also antihypertensive or affect the blood pressure, other than which provided by the research.
- Stroke or CHD patients who are diagnosed within 6 months. CHD patients are identified by being diagnosed by coronary arteriography or coronary CT angiography, having received coronary stent or coronary artery bypass surgery, or being diagnosed with acute myocardial infarction. Stroke patients are identified by being diagnosed with cerebral thrombosis, cerebral embolism, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack.
- Patients who are clearly diagnosed with following diseases: Congenital disease, myocardiopathy, serious arrhythmia, pulmonary heart disease, various of cardiac failure.
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 |
|---|---|---|
| TelmisartanAlso: China Resources Double-crane Pharmaceutical Co., Ltdcapsule,40mg per day,2 months | Drug | Telmisartan |
| HydrochlorothiazideAlso: Tianjin LiSheng Pharmaceutical Co., Ltdtablet, 25mg per day, 2 months | Drug | Hydrochlorothiazide |
Primary outcome
The difference between 2 groups of the decrease ranges of SBPs before and after the intervention of the subjects
Time frame: 2 months
We will measure the SBP for all the participants( around 1400) at baseline and 2\4\8 weeks after intervention with Omron electronic sphygmomanometer HBP - 1300. We will compare the differences between 2 groups at all 4 time points.
1 secondary outcome
The between-group difference of the decrease ranges of DBPs before and after the intervention of the subjects
Time frame: 2 months
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 11 Mar 2015.
- Derived from this study: PubMed 28509725Zhang P, Wang H, Sun L, Zhang J, Xi Y, Wu Y, Yan LL, Li X, Sun N. Telmisartan and hydrochlorothiazide antihypertensive treatment in high sodium intake population: a randomized double-blind trial. J Hypertens. 2017 Oct;35(10):2077-2085. doi: 10.1097/HJH.0000000000001407.
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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.
Zhang Pu Hong principal investigator
The George Institute
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telmisartan and Hydrochlorothiazide in people with Hypertension, run by The George Institute for Global Health, China at 14 sites 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 5 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: finished, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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.
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?
The difference between 2 groups of the decrease ranges of SBPs before and after the intervention of the subjects (time frame: 2 months). 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 NCT02255253, which also lists 1 linked publication.
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 11 Mar 2015.