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Telmisartan and Hydrochlorothiazide Antihypertensive Treatment Study in High Sodium Intake Population

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ClinicalTrials.gov Identifier: NCT02255253
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : March 11, 2015
Sponsor:
Collaborator:
Peking University People's Hospital
Information provided by (Responsible Party):
Puhong Zhang, The George Institute for Global Health, China

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Hypertension Drug: Telmisartan Drug: Hydrochlorothiazide Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1410 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Telmisartan
capsule,40mg per day,2 months
 Drug: Telmisartan
capsule,40mg per day,2 months
Other Name: China Resources Double-crane Pharmaceutical Co., Ltd
Experimental: Hydrochlorothiazide
tablet, 25mg per day, 2 months
 Drug: Hydrochlorothiazide
tablet, 25mg per day, 2 months
Other Name: Tianjin LiSheng Pharmaceutical Co., Ltd


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The between-group difference of the decrease ranges of DBPs before and after the intervention of the subjects [ Time Frame: 2 months ]
    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.


Other Outcome Measures:
  1. The between-group difference of the blood pressure control rates before and after the intervention of the subjects [ Time Frame: 2 months ]
    The patients whose SBP is less than 140 (150 for the old) and DBP less than 90 are thought to be controlled.

  2. The between-group difference of the changing ranges of FBG testing results before and after the intervention of the subjects [ Time Frame: 2 months ]
    Blood samples will be collected at baseline and the end of 2-month intervention for FBG test.

  3. The between-group difference of the incidence rates of hypokalemia after the intervention of the subjects [ Time Frame: 2 months ]
    Blood samples will be collected at baseline and the end of 2-month intervention for test


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255253


Locations
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China, Hebei
Chinese Traditional Medicine Hospital of Anguo
Baoding, Hebei, China, 071200
Boye hospital
Baoding, Hebei, China, 071300
Lixian chinese traditional medicine hospital
Baoding, Hebei, China, 071400
Gaoyang hospital
Baoding, Hebei, China, 071500
People's hospital in Rongcheng
Baoding, Hebei, China, 071700
Mancheng Hospital
Baoding, Hebei, China, 072150
Shunping Hospital
Baoding, Hebei, China, 072250
People's hospital of Tangxian
Baoding, Hebei, China, 072350
Wangdu hospital
Baoding, Hebei, China, 072450
Gaobeidian hospital
Baoding, Hebei, China, 074000
Central hospital in Baigou
Baoding, Hebei, China, 074004
The second hospital of Lai Shui
Baoding, Hebei, China, 074100
Wenan Hospital
Lanfang, Hebei, China, 065800
Dacheng chinese traditional medicine hospital
Langfang, Hebei, China, 065900
Sponsors and Collaborators
The George Institute for Global Health, China
Peking University People's Hospital
Investigators
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Principal Investigator: Zhang Pu Hong The George Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Puhong Zhang, Associate Professor, The George Institute for Global Health, China
ClinicalTrials.gov Identifier: NCT02255253     History of Changes
Other Study ID Numbers: 2013BAI05B02
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015
Keywords provided by Puhong Zhang, The George Institute for Global Health, China:
Telmisartan
Hydrochlorothiazide
Efficacy
hypertension
high sodium intake
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Telmisartan
Antihypertensive Agents
Diuretics
 Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists