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Trial record 4 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

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

Tracking Information
First Submitted Date  ICMJE September 24, 2014
First Posted Date  ICMJE October 2, 2014
Last Update Posted Date March 11, 2015
Study Start Date  ICMJE October 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02255253 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 1, 2014)
  • 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.
  • 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.
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Telmisartan and Hydrochlorothiazide Antihypertensive Treatment Study in High Sodium Intake Population
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Telmisartan
    capsule,40mg per day,2 months
    Other Name: China Resources Double-crane Pharmaceutical Co., Ltd
  • Drug: Hydrochlorothiazide
    tablet, 25mg per day, 2 months
    Other Name: Tianjin LiSheng Pharmaceutical Co., Ltd
Study Arms  ICMJE
  • Experimental: Telmisartan
    capsule,40mg per day,2 months
    Intervention: Drug: Telmisartan
  • Experimental: Hydrochlorothiazide
    tablet, 25mg per day, 2 months
    Intervention: Drug: Hydrochlorothiazide
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2015)
1410
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2014)
1200
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02255253
Other Study ID Numbers  ICMJE 2013BAI05B02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Puhong Zhang, The George Institute for Global Health, China
Study Sponsor  ICMJE The George Institute for Global Health, China
Collaborators  ICMJE Peking University People's Hospital
Investigators  ICMJE
Principal Investigator: Zhang Pu Hong The George Institute
PRS Account The George Institute for Global Health, China
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP