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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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18 April 2017 |
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Main ID: |
ChiCTR-PRC-08000217 |
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Date of registration:
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2008-12-07 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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CHINOM, sub-project of CHIEF, a project of The National 11th Five-year plan, Science-Technology Ministry
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Scientific title:
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Chinese HIgh-NOrmal BP Management study |
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Date of first enrolment:
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2008-01-27 |
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Target sample size:
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Telmesartan group:1200;Beijing 0 group:1200;placebo group:1200;Indapamide group:1200; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=9309 |
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Study type:
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Prevention |
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Study design:
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Randomized parallel controlled trial
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Phase:
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Post-market
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Countries of recruitment
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China
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Contacts
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Name:
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Hesheng Xue
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Address:
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Rm.725, A2, Bai Lang Yuan; No.A36 Fuxing Rd., Haidian Dist., Beijing
100039
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Telephone:
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+86 0 13581966082 |
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Email:
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hshxue@sohu.com |
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Affiliation:
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CHINOM group |
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Name:
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Lisheng Liu
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Address:
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Rm.725, A2, Bai Lang Yuan, No.A36 Fuxing Rd., Haidian Dist., Beijing
100039
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Telephone:
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+86 010 88204088 |
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Email:
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llshypt@yahoo.com.cn |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Age: 50-79(f)/45-79(m);
2. Blood pressure: 130<=SBP<140mmHg and DBP<90mmHg or 85<=DBP<90mmHg and SBP<140mmHg;
3. At least one of other cardiovascular risk factors;
4. Informed consent obtained.
Exclusion criteria: 1. Diabetes mellitus(FPG>=7.0mmol/L and/or OGTT 2hPG>=11.1mmol/L);
2. Hypertensive patients(SBP>=140 mmHg and/or DBP>=90 mmHg);
3. Patients participating any other studies within three months or concomitantly;
4. Presence of renal dysfunction, Cr >133 mmol/L, or BUN > 14.2mmol/L;
5. Presence of hepatic dysfunction (AST and/or ALT is 3 times higher than normal limit);
6. Serum k+<3.5 mmol/L or >5.6 mmol/L;
7. Hypersensitive to study agents;
8. Stroke or myocardial infarction within 6 months of the enrollment;
9. PTCA or CABG within 2 months prior to the study;
10. Presence of malignant tumors or other serious diseases;
11. Pregnant or lactating women; women in reproductive age not using recognized contraceptive methods;
12. Impossible for follow up;
13. Indications of hypotensive drugs;
14. Indications or contraindication of study drugs;
15. Unsuitable for the study judged by physician in charge.
Age minimum:
45
Age maximum:
79
Gender:
Both
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Health Condition(s) or Problem(s) studied
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I10-I14 I20 I60-I69
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Hypertension, Cardiovascular diseases
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Intervention(s)
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Telmesartan group:telmesartan capsule 40mg/day;Beijing 0 group:Beijing 0 tablets 0.5#/qd;placebo group:placebo tablets 0.5#/qd;Indapamide group:Indapamide 1.5mg/capsule, once two days;
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Primary Outcome(s)
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combined cardiovascular events, new onset hypertention;
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Secondary Outcome(s)
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fatal and nonfatal stroke or MI, cardiovascular death;
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Source(s) of Monetary Support
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11th National Five-Year Plan + Sponsorship
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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