A Phase I Randomised, Placebo-Controlled, Double-Blind Study in Hypertensive Patients of the Blood Pressure Interaction Between TC-5214 and Anti-Hypertensive Medications (Calcium Channel Blockers, Beta Blockers, and ACE Inhibitors)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Part 1: To measure the effect of TC-5214 on sitting blood pressure in patients with chronic hypertension.
研究概览
简要总结
This is a two part study. Part 1 will determine determine if administration of TC-5214 has an effect on sitting blood pressure in patients with chronic hypertension.
Part 2 will determine any possible interactions between TC-5214 and Anti-Hypertensive Medications (Calcium Channel Blockers, Beta Blockers, and ACE Inhibitors).
详细描述
A Phase I Randomised, Placebo-Controlled, Double-Blind Study in Hypertensive Patients of the Blood Pressure Interaction between TC-5214 and Anti-Hypertensive Medications (Calcium Channel Blockers, Beta Blockers, and ACE Inhibitors)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures
- •Male or female patients with chronic, stable hypertension treated for at least 1 month before screening with a calcium channel blocker, a beta blocker, or an ACE inhibitor, either as the only anti-hypertensive medication or concurrently with a diuretic. The patients should have no change in their current anti hypertensive treatment for at least 1 month before dosing
- •Patients in Part 1 should have an SBP of ≤140 mmHg at screening and ≤160 mmHg at Visit 1a and pre-dose on Day 1
- •Patients in Part 2 should have an SBP of ≤160 mmHg at screening Visit 1 and pre dose on Day
- •Systolic blood pressure and DBP should not vary by more than 8 mmHg and 5 mmHg, respectively, in the pre-dose period (screening, Visit 1a, and pre-dose on Day 1)
- •Age 18 to 65 years (inclusive)
排除标准
- •Other than having chronic hypertension, the history of any clinically significant medical, neurologic, or psychiatric disease or disorder which, in the opinion of the Investigator and/or the Sponsor, may either put the patient at risk because of participation in the study or influence the results, or the patient's ability to participate in the study. Patients with dyslipidaemia (diet controlled or treated with a statin) and/or metabolic syndrome (diet controlled or treated with metformin) may be entered into the study
- •Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product
- •Patients with a pre-treatment SBP (if known) of >180 mmHg or a history of accelerated or malignant hypertension based on grade III (hypertensive haemorrhages and/or cotton wool spots) or grade IV (hypertensive papilloedema) retinopathy at any time
- •History or presence of gastrointestinal (including irritable bowel disease), hepatic, or renal disease (creatinine clearance of ≤50 mL/minute calculated using the Cockcroft Gault equation) or any other condition known to interfere with the ADME of the investigational product.
- •Patients with a history of surgery on the gastrointestinal tract (not including appendectomy or cholecystectomy) should also be excluded
- •Any significant ECG abnormality including QTcF prolongation (>450 ms) or significant arrhythmias, or junctional rhythms
研究组 & 干预措施
1
TC-5214
干预措施: TC-5214 (Drug)
2
TC-5214 with placebo
干预措施: TC-5214 (Drug)
3
TC-5214 with placebo
干预措施: TC-5214 (Drug)
4
TC-5214
干预措施: TC-5214 (Drug)
结局指标
主要结局
Part 1: To measure the effect of TC-5214 on sitting blood pressure in patients with chronic hypertension.
时间窗: Day 1 through to follow up
The following assessments will be measured and reported: - A change from baseline in blood pressure and pulse rate.
Part 2: To measure the effect of TC-5214 combined with treatment with the common classes of anti-hypertensive medication (calcium channel blockers, beta blockers, angiotensin converting enzyme inhibitors) on sitting blood pressure.
时间窗: Day 1 through to follow up
The following assessments will be measured and reported: A change from baseline in blood pressure and pulse rate.
次要结局
- To examine the safety and tolerability of TC-5214.(Day 1 through to Follow up)
- The concentration of TC-5214 in plasma will be measured.(Day 1 to day 28)