PACTR202107579572114招募中未知
Evaluation of a triple single-pill combination (triple pill)-based treatment protocol compared to the Nigeria hypertension treatment protocol for improving BP control in Nigeria.
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 13 Year(s) 至 18 Year(s)（—）
- 性别
- All
入选标准
- •At screening visit
- •1.Black African
- •2.Adult (age =18 years)
- •3.Provided signed consent to participate in the study
- •4.Untreated or on one BP-lowering medication for =2 weeks
- •5.Needs initiation or intensification of BP-lowering medication(s) therapy as per the investigator’s judgement based
- •on BP at this and/or previous visits
- •6.Willingness to use home BP measurement device and measure BP at home for 6 months
- •At randomisation visit
- •1.Untreated or on one BP-lowering medication for =2 weeks
- •2.Clinic attended automated seated mean SBP (average of last 2 measurements): 140-179 mmHg and/or DBP 90-
- •3. Willingness to use home BP measurement device and measure BP at home for 6 months
- •4. Needs initiation or intensification of BP-lowering medication(s) therapy as per the investigator’s judgement based
- •on BP at this and/or previous visits
排除标准
- •At Screening and randomisation visit
- •1.Receiving 2 or more BP-lowering medications. (a single pill combination containing two different BP-lowering medications should be considered as 2 BP-lowering medications)
- •2.Receiving any BP lowering medications for indications other than hypertension (e.g., heart failure)
- •3.Current/history of congestive heart failure
- •4.Current/history of coronary heart disease including angina, myocardial infarction, or acute coronary syndrome
- •5.Current/history of atrial fibrillation
- •6.Current/history of a stroke or transient ischemic attack
- •7.Known or suspected secondary hypertension
- •8.Hyper-/hypothyroidism, pheochromocytoma, or arteriovenous fistula
- •9.Current/history of Raynaud’s disease
- •10.Uncontrolled diabetes mellitus (glycosylated haemoglobin >11% [> 97 mmol/mol]) within last three months
- •11.Current/history of end-stage renal disease or anuria or current estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2)
- •12.Pregnancy, or had a positive pregnancy test, or unwilling to undertake a pregnancy test before randomisation, and/or during the study, and up to 14 days after the discontinuation of the study medication, or breastfeeding, or of childbearing age and not using highly effective method of contraception
- •13.Not suitable for participation in a clinical study according to local ethical or regulatory requirements related to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)
- •14.Contraindication, including hypersensitivity (e.g., anaphylaxis or angioedema) to any of the study medications or procedures
- •15.Participation in any investigational medication and/or device study within the 30 days prior to randomisation
- •16.Current concomitant illness or physical impairment or mental condition or abnormal laboratory value, which in the judgment of the investigator could interfere with the effective conduct of the study or constitutes a significant risk to the participants’ safety or well-being
研究者
相似试验
招募中
3 期
Evaluation of the effect of interferon beta-1b in the treatment of COVID-19IRCT20200921048786N1Dezfoul University of Medical Sciences82
招募中
2 期
effect of valsartan / amlodipine on LVDDCondition 1: hypertension. Condition 2: Left ventricular diastolic dysfunction.Essential (primary) hypertensionDiastolic (congestive) heart failureI50.3IRCT20201102049232N1Qazvin University of Medical Sciences122
招募中
不适用
comparison of three combinations of two blood pressure lowering drugs on central arterial stiffness and pressure in patients with hypertensioCTRI/2022/11/047463Imperial College of London
终止
3 期
Alisporivir With PEG and RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis CHepatitis CNCT01500772Debiopharm International SA6
已完成
不适用
Efficacy of a Single dose versus Triple Dose Regimen of Mebendazole against Hookworm infections among School Children: Randomized trial.PACTR201911466695052niversity of Gondar108