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项与 奥美沙坦酯/烟酸氨氯地平 相关的临床试验Multi-Omics to Predict the Blood Pressure Response to Antihypertensives
The goal of this clinical trial is to develop biomarkers composed of multiple OMICs (MOMICs) for prediction of blood pressure response to antihypertensive drugs in the treatment of primary hypertension. The main objectives are:
Primary objective:
- To identify MOMICs biomarkers that predict the response in 24-hour blood pressure to antihypertensive treatment for each treatment group (olmesartan, amlodipine, hydrochlorothiazide, olmesartan/amlodipine)
Secondary objectives:
To identify a MOMICs biomarker that predict the response in night-time blood pressure to anti-hypertensive treatment for each treatment group (olmesartan, amlodipine, hydrochlorothiazide, olmesartan/amlodipine)
To identify MOMICs biomarkers that predict side effects, including changes in QoLof olmesartan, amlodipine and hydrochlorothiazide.
Exploratory objective:
To assess changes in MOMICs biomarkers induced by each drug
Participants will undergo three 4-week treatment periods:
Each subject receives 3 out of 4 possible treatments (olmesartan, amlodipine, hydrochlorothiazide, olmesartan/amlodipine).
Before and after each treatment period OMICS measurements and an ABPM are performed.
At the end of each treatment period blood is sampled for drug level testing to assess adherence.
Electrolytes and kidney function are checked 5-7 days after start of each treatment period.
A Randomized, Open-label, Single-Dose, 2-Treatment, 2-Way, 2-Period Crossover Study to Assess the Safety and the Pharmacokinetic Characteristics of Lodivikar tab. 5/40 mg in Healthy Adult Male Subjects
A Randomized, Open-label, Single-Dose, 2-Treatment, 2-Way, 2-Period Crossover Study to Assess the Safety and the Pharmacokinetic Characteristics of Lodivikar Tab. 5/40 mg in Healthy Adult Male Subjects
The purpose of this study is to assess the pharmacokinetic characteristics of olmesartan and S-amlodipine after single oral administration of Sevikar tab. 10/40mg, a combination formulation of olmesartan and amlodipine as reference drug and Lodivikar tab. 5/40mg, a combination formulation of olmesartan and S-amlodipine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.
100 项与 奥美沙坦酯/烟酸氨氯地平 相关的临床结果
100 项与 奥美沙坦酯/烟酸氨氯地平 相关的转化医学
100 项与 奥美沙坦酯/烟酸氨氯地平 相关的专利(医药)
100 项与 奥美沙坦酯/烟酸氨氯地平 相关的药物交易