A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Blood Pressure Reduction With Ambulatory Blood Pressure Monitoring (ABPM), Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Hypertension and Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 171
- 主要终点
- Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6
研究概览
简要总结
The purpose of this study is to evaluate the effect of canagliflozin (JNJ-28431754) on blood pressure reduction, compared to placebo, in patients with hypertension and type 2 diabetes mellitus and who are on stable doses of anti-hyperglycemic and anti-hypertensive agents. Overall safety and tolerability of canagliflozin will be assessed.
详细描述
This is a randomized (study drug assigned by chance), double blind (neither the patient nor the study doctor will know the name of the assigned treatment), parallel-group, 3-arm (patients will be assigned to 1 of 3 treatment groups) multicenter study to determine the effect of canagliflozin (100 mg and 300 mg) on blood pressure (BP) reduction compared to placebo (a pill that looks like all the other treatments but has no real medicine) in patients with hypertension and type 2 diabetes mellitus (T2DM). The study will consist of 3 phases: a screening phase, a double-blind treatment phase and a follow-up period. Approximately 153 participants will be randomly assigned to 1 of 3 treatment groups (in a 1:1:1 ratio) in the double-blind treatment phase to receive canagliflozin 100 mg, canagliflozin 300 mg or placebo for 6 weeks. The total duration of participation in this study will be approximately 13 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a diagnosis of type 2 diabetes mellitus
- •patients with hypertension (seated office SBP of >=130 mmHg and <160 mmHg and seated office DBP of >= 70 mmHg at screening and at Week -2
- •patients on stable doses of 1 to 3 anti-hypertensive agents for at least 5 weeks before screening
- •patients on stable doses of 1 to 3 oral anti-hyperglycemic agents which must include metformin, for at least 8 weeks before screening
排除标准
- •a history of diabetic ketoacidosis
- •type 1 diabetes mellitus (T1DM)
- •pancreas or beta-cell transplantation
- •fasting C-peptide <0.70 ng/mL (0.23 nmol/L)
- •body mass index <30 kg/m2
- •has ongoing, inadequately controlled thyroid disorder
- •has a history of cardio-renal disease that required treatment with immunosuppressive therapy.
研究组 & 干预措施
Canagliflozin 100 mg
Each patient will receive 100 mg of canagliflozin once daily for 6 weeks.
干预措施: Canagliflozin (Drug)
Canagliflozin 300 mg
Each patient will receive 300 mg of canagliflozin once daily for 6 weeks.
干预措施: Canagliflozin (Drug)
Placebo
Each patient will receive matching placebo once daily for 6 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6
时间窗: Baseline and Week 6
The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.
次要结局
- Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2(Baseline and Day 2)
- Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6(Baseline, Day 2 and Week 6)
- Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6(Baseline, Day 2, Week 3 and 6)
- Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6(Baseline, Day 2 and Week 6)
- Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6(Baseline, Day 2 and Week 6)
- Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6(Baseline, Day 2 and Week 6)
- Change From Baseline in Body Weight to Week 6(Baseline and Week 6)
- Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6(Baseline, Day 2, Week 3 and 6)
- Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6(Baseline, Day 2, Week 3 and 6)
- Change From Baseline in the Difference in Seated Heart Rate (HR) and Standing HR to Day 2, to Week 3, and to Week 6(Baseline, Day 2, Week 3 and 6)
- Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6(Baseline and Week 6)
- Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6(Baseline, Day 2, Week 3 and 6)
- Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6(Baseline, Day 2 and Week 6)
- Change From Baseline in the Difference in Seated Office Blood Pressure (BP) and Standing Office BP to Day 2, to Week 3, and to Week 6(Baseline, Day 2, Week 3 and 6)