Telmisartan and Hydrochlorothiazide Antihypertensive Treatment Study in High Sodium Intake Population
Information source: The George Institute for Global Health, China
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Telmisartan (Drug); Hydrochlorothiazide (Drug)
Phase: N/A
Status: Completed
Sponsored by: The George Institute for Global Health, China Official(s) and/or principal investigator(s):
Zhang Pu Hong, Principal Investigator, Affiliation: The George Institute
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. 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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The difference between 2 groups of the decrease ranges of SBPs before and after the intervention of the subjects
Secondary outcome: The between-group difference of the decrease ranges of DBPs before and after the intervention of the subjects
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Locations and Contacts
Boye hospital, Baoding, Hebei 071300, China
Central hospital in Baigou, Baoding, Hebei 074004, China
Chinese Traditional Medicine Hospital of Anguo, Baoding, Hebei 071200, China
Gaobeidian hospital, Baoding, Hebei 074000, China
Gaoyang hospital, Baoding, Hebei 071500, China
Lixian chinese traditional medicine hospital, Baoding, Hebei 071400, China
Mancheng Hospital, Baoding, Hebei 072150, China
People's hospital in Rongcheng, Baoding, Hebei 071700, China
People's hospital of Tangxian, Baoding, Hebei 072350, China
Shunping Hospital, Baoding, Hebei 072250, China
The second hospital of Lai Shui, Baoding, Hebei 074100, China
Wangdu hospital, Baoding, Hebei 072450, China
Wenan Hospital, Lanfang, Hebei 065800, China
Dacheng chinese traditional medicine hospital, Langfang, Hebei 065900, China
Additional Information
Starting date: October 2014
Last updated: March 9, 2015
|
