Treatment of Hypertension in Tibetan Adult Population

NCT02217852 | Unknown Phase 4 DMC

• 1 other identifier: WestChinaH 20140701
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

hypertension; Tibetan; Nitrendipine; hydrochlorothiazide; captopril; Beijing hypotensive No.0

Outcome Measures

Primary Outcomes (1)

• Change of Blood Pressure

  Change of systolic blood pressure，diastolic blood pressure and mean arterial pressure from baseline to study end at 12 months.

  12 months

Secondary Outcomes (1)

• Change of target organ damage

  12 months

Study Arms (4)

A1 nitrendipine

EXPERIMENTAL

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

A2 hydrochlorothiazide

EXPERIMENTAL

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

B1 captopril plus Hydrochlorothiazide

EXPERIMENTAL

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

B2 Beijing hypotensive No.0

EXPERIMENTAL

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

Interventions

Nitrendipine DRUG

doses used range from 10-20mg po bid. Total duration would be until completion or study or medication intolerance.

A1 nitrendipine

Hydrochlorothiazide DRUG

doses used range from 12.5-25mg po qd. Total duration would be until completion or study or medication intolerance.

A2 hydrochlorothiazide

Captopril,Hydrochlorothiazide DRUG

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.

B1 captopril plus Hydrochlorothiazide

Beijing hypotensive No.0 DRUG

1 pile po qd or less. Total duration would be until completion or study or medication intolerance.

Also known as: compound hypotensive tablet

B2 Beijing hypotensive No.0

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

Nitrendipine; Hydrochlorothiazide; captopril, hydrochlorothiazide drug combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Xiaoping Chen, MD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoping Chen, MD

CONTACT

86-028-85422175; xiaopingchen11@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of Department of Internal Medicine

Study Record Dates

• First Submitted: August 13, 2014
• First Posted: August 15, 2014
• Study Start: August 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 29, 2014

Record last verified: 2014-08

Locations

CN (1)