Skip to main content
OpenTrials
Completed

NCT Number: NCT02255253

Telmisartan and Hydrochlorothiazide Antihypertensive Treatment Study in High Sodium Intake Population

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boye hospital, Baoding, Hebei, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telmisartan

Drug

capsule,40mg per day,2 months

Other names: China Resources Double-crane Pharmaceutical Co., Ltd

Hydrochlorothiazide

Drug

tablet, 25mg per day, 2 months

Other names: Tianjin LiSheng Pharmaceutical Co., Ltd

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The George Institute for Global Health, China

Other

Collaborators

  • Peking University People's Hospital

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 2, 2014
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.