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II period clinical research of compound candesartan ester (candesartan ester 16 mg/hydrochlorothiazide 12.5 mg) in the treatment of Chinese patients with primary hypertension

A randomized, double-blind, controlled, multicenter clinical study of efficacy, safety, and tolerability of compound Candesartan tablets (candesartan 16mg/ hydrochlorothiazide 12.5mg) in Chinese patients with essential hypertension.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041306
Enrollment
Unknown
Registered
2020-12-23
Start date
2005-07-01
Completion date
Unknown
Last updated
2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

the monotherapy treatment period:Candesartan 16mg was taken
Randomized double-blind treatment period:Compound Candesartan ester (Can16/HCTZ12.5)
Randomized double-blind treatment period:Candesartan 8mg

Sponsors

Institute of Fuwai Cardiovascular Disease Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Male or female outpatients, aged from 18 to 65 years; 2. Patients with history of essential hypertension; 3. The blood pressure of patients with essential hypertension meets the following conditions. (1) Pre study: in the period of antihypertensive treatment, 90 mmHg <= sedbp < 115 mmHg and sedbp < 180 mmHg after discontinuation of all antihypertensive drugs on the same day; 95 mmHg <= sedbp < 115 mmHg and sesbp < 180 mmHg for those who did not take antihypertensive drugs (within 14 days); (2) After 1-2 weeks of cleaning: all patients had 95 mmHg <= sedbp < 115 mmHg and sesbp < 180 mmHg; (3) Monotherapy: all patients 95 mmHg <= sedbp < 115 mmHg and sesbp < 180 mmHg; 4. Patients with written informed consent; 5. Randomized double-blind treatment period: the patients' blood pressure was 95mmhg <= sedbp < 115mmhg and sesbp < 180mmhg.

Exclusion criteria

Exclusion criteria: 1. Single drug treatment period: (1) Average sedbp >= 115mmhg or average sesbp >= 180mmhg; (2) Patients with evidence of secondary hypertension, such as coarctation of the great arteries, aldosteronism, unilateral or bilateral renal disease or angiocytoma; (3) Patients with a history of coronary heart disease (including treated or untreated angina pectoris, myocardial infarction) and history of coronary artery reconstruction in the past 6 months; (4) Patients with a history of heart failure; (5) Patients with any serious arrhythmia; (6) Patients with history of hypertensive encephalopathy and cerebrovascular disease had transient ischemic attack in the past 6 months; (7) Patients with type 1 diabetes mellitus, type 2 diabetes mellitus with poor glycemic control; (8) Body mass index > 30 kg / m2; (9) Patients with known chronic or acute renal failure; (10) Patients with clinically significant liver diseases; (11) Patients with a history of malignant tumor or any life-threatening history of liver, kidney, heart and lung dysfunction in the past 5 years; (12) Patients with known hypokalemia or hyperkalemia; (13) Patients with known hyperuricemia and / or ventilation; (14) Patients with known hypersensitivity or contraindication to candesartan cilexetil or other angiotensin II receptor antagonists, patients with known hypersensitivity or contraindication to sulfonamides or thiazide diuretics, and patients with known hypersensitivity or contraindication to candesartan cilexetil or other angiotensin II receptor antagonists; (15) According to the judgment of the researcher, patients with other lesions that reduce the possibility of enrollment or complicate the enrollment; (16) Any other drugs that may affect blood pressure; (17) The patients who used tricyclic antidepressants, antipsychotics, lithium, chlorphenamine butyric acid, and sutobilide; (18) High dose salicylate was used in patients with NSAIDs; (19) If the patients who use glucocorticoid and mineralocorticoid have been treated for more than 10 days and can not be stopped within 5 days before A0; (20) Thyroid drugs and / or estrogen replacement therapy should not be used during the trial period unless a stable continuous replacement dose has been taken 6 months before the trial; (21) Stop using hormone contraception at least one month before A0; (22) Patients using other drugs that may affect the water electrolyte balance; (23) Pure potassium salt or other drugs containing potassium salt were taken until W0; (24) Patients who use traditional Chinese medicine, proprietary Chinese medicine or natural medicine without doctor's permission; (25) Those patients who could not safely stop using all antihypertensive drugs within 2 weeks according to the trial protocol; (26) Patients who had a history of drug abuse and excessive drinking in the past two years; (27) Patients who had a history of not taking medicine according to the regulations, or were unwilling to comply with the provisions of the trial protocol; (28) Patients with mental or legal disabilities; (29) Pregnant and lactating women; (30) Subjects who participated in any drug experiment within 3 months before the first visit (A0); (31) Any situation that the researcher believes will endanger the effectiveness and safety of the drug. 2. Randomized double-blind treatment period (1) Average sedbp >= 115mmhg or average sesbp >= 180mmhg; (2) Patients with a history of coronary heart disease (including t

Design outcomes

Primary

MeasureTime frame
SeDBP;

Secondary

MeasureTime frame
SeSBP;

Countries

China

Contacts

Public ContactLi Yishi

Fuwai Cardiovascular Hospital

lchyl_fuwai@sina.com+86 10-88398395

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026