Treatment of Hypertension in Tibetan Adult Population - Full Text View

Purpose

Several surveys had revealed that Tibetan adults had high prevalence of hypertension. However, there was no research studying the antihypertensive effect of the known drugs in Tibetan. The main arms of our study were to determine if the efficacy of lowing blood pressure and protecting target organ damage differs between nitrendipine and Hydrochlorothiazide in mild hypertension in Tibetan, and to determine if the efficacy of lowing blood pressure and protecting target organ damage differs between captopril plus Hydrochlorothiazide and Beijing hypotensive No.0 in moderate and severe Tibetan hypertension.

Condition	Intervention	Phase
Hypertension	Drug: Nitrendipine Drug: Hydrochlorothiazide Drug: Captopril,Hydrochlorothiazide Drug: Beijing hypotensive No.0	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open-label, Positive Drug Controlled Clinical Trials to Compare the Efficacy of Nitrendipine and Hydrochlorothiazide , Captopril Plus Hydrochlorothiazide and Beijing Hypotensive No.0 in Tibetan Hypertension

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines

Drug Information available for: Hydrochlorothiazide Captopril

U.S. FDA Resources

Further study details as provided by Xiaoping Chen, West China Hospital:

Primary Outcome Measures:

Change of Blood Pressure [ Time Frame: 12 months ]
Change of systolic blood pressure，diastolic blood pressure and mean arterial pressure from baseline to study end at 12 months.

Secondary Outcome Measures:

Change of target organ damage [ Time Frame: 12 months ]
Change of target organ damage(including estimated glomerular filtration rate, microalbuminuria, carotid intima-media thickness, arterial stiffness, left ventricular mass index) from baseline to study end at 12 months.


Estimated Enrollment:	800
Study Start Date:	August 2014
Estimated Study Completion Date:	July 2016
Estimated Primary Completion Date:	January 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A1 nitrendipine this arm will include Tibetan patients with hypertension whose BP is higher than 140/90mmHg but lower than 160/100mmHg and nitrendipine will be added (dose range 10mg-20mg bid).	Drug: Nitrendipine doses used range from 10-20mg po bid. Total duration would be until completion or study or medication intolerance.
Experimental: A2 hydrochlorothiazide this arm will include Tibetan patients with hypertension whose BP is higher than 140/90mmHg but lower than 160/100mmHg and hydrochlorothiazide will be added (dose range 12.5mg-25mg)	Drug: Hydrochlorothiazide doses used range from 12.5-25mg po qd. Total duration would be until completion or study or medication intolerance.
Experimental: B1 captopril plus Hydrochlorothiazide this arm will include Tibetan patients with hypertension whose BP is higher than 160/100mmHg and captopril plus Hydrochlorothiazide will be added (dose range：captopril 25mg-50mg tid, Hydrochlorothiazide 12.5mg-25mg qd).	Drug: Captopril,Hydrochlorothiazide doses used range from 25-50mg po tid for captopril and 12.5-25mg po qd for hydrochlorothiazide. Total duration would be until completion or study or medication intolerance.
Experimental: B2 Beijing hypotensive No.0 this arm will include Tibetan patients with hypertension whose BP is higher than 160/100mmHg and Beijing hypotensive will be added (dose range：Beijing hypotensive No.0 one pile qd or less ).	Drug: Beijing hypotensive No.0 1 pile po qd or less. Total duration would be until completion or study or medication intolerance. Other Name: compound hypotensive tablet

Detailed Description:

Several surveys had revealed that Tibetan adults had high blood pressure(BP)and prevalence of hypertension than other parts of China and were also higher than those in developed nations as well. For example, one study found that among Tibetan herdsmen 40 years and older, the prevalence of hypertension was 56% and the mean systolic blood pressure/diastolic blood pressure was 146.6/92.0mmHg. However, the rates of awareness, treatment, and control were dismally low.

The Tibetan have been living in the Tibetan Plateau. The special natural and social environment there，as well as ethnic ,may all be involved in the etiology of the high prevalence and effect the response to antihypertensive treatment. Nevertheless, few interventional studies have been done in Tibetan hypertensive patients. Therefore, the purpose of our study was to compare the blood pressure reduction between different antihypertensive drugs. Nitrendipine, hydrochlorothiazide, captopril and Beijing hypotensive No.0 (also named" compound hypotensive tablet") are selected, which are cheap and available in the Tibetan Plateau.

Nitrendipine, hydrochlorothiazide and captopril are the representatives of Dihydropyridines Calcium antagonists, diuretics, and angiotensin-converting enzyme inhibitors, respectively. They are all recommended as the first-line antihypertensive drug. Beijing hypotensive No.0 is produce by China Resources Double-crane Pharmaceutical company in China, and it is a fixed-dose combination containing reserpine 0.1mg, hydrochlorothiazide 12.5mg, dihydralazine sulfate 12.5mg, triamterene 12.5mg. Many studies conducted in China have demonstrated its efficacy and safety in lowing blood pressure.

After recruitment, participant will be grouped according to their BP. If BP＜160/100mmHg, monotherapy is started. Patient is randomly assigned to receive nitrendipine 10mg bid or Hydrochlorothiazide 12.5mg qd. If BP≥160/100mmHg, Patient is randomly assigned to receive two drug combination therapy(captopril 25mg three times daily (tid) and Hydrochlorothiazide 12.5mg qd) or Beijing hypotensive No.0 one pile qd. During the following 12 months，each participant will take at least four visits at 1、3、6 and 12 months respectively. Goal BP for all participants was less than 140/90mmHg, achieved by titrating the assigned study drug and adding open-label agents when necessary. The maximum dosage is 20mg BID for nitrendipine, 25mg qd for Hydrochlorothiazide and 50mg tid for captopril. The dosage of Beijing hypotensive No.0 should not be added.

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult Tibetan, who have been living in the Tibetan Plateau since he/she was born.
Consistent with diagnosed hypertension, blood pressure, for 1-3 grade.
Aged 18-80 years old.
To sign informed consent.

Exclusion Criteria:

diagnosis of secondary hypertension
Hypertensive emergencies and urgencies
Malignant hypertension
Bilateral renal artery stenosis, Chronic Kidney Disease（CKD）, serum creatinine> 133μmol / L.
Suffering from congenital heart disease, rheumatic heart disease, hypertrophic cardiomyopathy, aortic stenosis.
Occurred within the past 6 months who had a stroke or transient ischemic attack (TIA), unstable angina, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA).
clinical significance of arrhythmia
Active liver disease, history of chronic persistent hepatitis, alanine aminotransferase（ALT）> upper limit of normal.
Pregnancy, pregnancy or breast-feeding women to prepare.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02217852

Contacts


Contact: Xiaoping Chen, MD	86-028-85422175	xiaopingchen11@126.com

Locations


China, Sichuan
West China Hospital	Not yet recruiting
Chengdu, Sichuan, China, 610041

Sponsors and Collaborators

West China Hospital

Investigators


Principal Investigator:	Xiaoping Chen, MD	West China Hospital

More Information


Responsible Party:	Xiaoping Chen, Deputy director of Department of Internal Medicine, West China Hospital
ClinicalTrials.gov Identifier:	NCT02217852 History of Changes
Other Study ID Numbers:	WestChinaH 20140701
Study First Received:	August 13, 2014
Last Updated:	August 28, 2014

Keywords provided by Xiaoping Chen, West China Hospital:


hypertension Tibetan Nitrendipine	hydrochlorothiazide captopril Beijing hypotensive No.0

Additional relevant MeSH terms:


Hypertension Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Nitrendipine Antihypertensive Agents Captopril Diuretics Natriuretic Agents	Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium Channel Blockers Vasodilator Agents Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 26, 2017