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Treatment of Hypertension in Tibetan Adult Population

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ClinicalTrials.gov Identifier: NCT02217852
Recruitment Status : Unknown
Verified August 2014 by Xiaoping Chen, West China Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 15, 2014
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
Xiaoping Chen, West China Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: Nitrendipine Drug: Hydrochlorothiazide Drug: Captopril,Hydrochlorothiazide Drug: Beijing hypotensive No.0 Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  1. diagnosis of secondary hypertension
  2. Hypertensive emergencies and urgencies
  3. Malignant hypertension
  4. Bilateral renal artery stenosis, Chronic Kidney Disease（CKD）, serum creatinine> 133μmol / L.
  5. Suffering from congenital heart disease, rheumatic heart disease, hypertrophic cardiomyopathy, aortic stenosis.
  6. Occurred within the past 6 months who had a stroke or transient ischemic attack (TIA), unstable angina, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA).
  7. clinical significance of arrhythmia
  8. Active liver disease, history of chronic persistent hepatitis, alanine aminotransferase（ALT）> upper limit of normal.
  9. Pregnancy, pregnancy or breast-feeding women to prepare.
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): NCT02217852


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

Locations
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China, Sichuan
West China Hospital
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China Hospital
Investigators
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Principal Investigator: Xiaoping Chen, MD West China Hospital
More Information
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Responsible Party: Xiaoping Chen, Deputy director of Department of Internal Medicine, West China Hospital
ClinicalTrials.gov Identifier: NCT02217852    
Other Study ID Numbers: WestChinaH 20140701
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: August 2014
Keywords provided by Xiaoping Chen, West China Hospital:
hypertension
Tibetan
Nitrendipine
 hydrochlorothiazide
captopril
Beijing hypotensive No.0
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Captopril
Nitrendipine
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
 Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Calcium Channel Blockers
Calcium-Regulating Hormones and Agents
Vasodilator Agents