To evaluate the safety and efficacy of fixed dose combination of Olmesartan and Metoprolol succinate ER in hypertensive patients with Cardiovascular Disease (CVD).
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 97
- 主要终点
- Magnitude of systolic and diastolic blood pressure reduction from baseline at end of 8 weeks of treatment
研究概览
简要总结
Study Plan Patients will be recruited based on the inclusion and exclusion criteria. In case of uncontrolled hypertension with base line therapy of diuretics or calcium channel blockers ? 2 weeks ?washout period? would be allowed before initiating the patient on combination. Written ?Informed consent? will be obtained from these patients after a thorough explanation of the study. Each patient will receive copy of ?Informed consent? form and ?Patient information? sheet. Patients will be explained regarding benefits and side effects of the treatment as per the available Prescribing Information. At the first visit (Baseline), detailed history and examination of the patients will be performed. Patients BP, Health-related quality of life questionnaire, Symptom-Distress index for fatigue, headache and dizziness would be assessed. During the second visit (after 4 weeks), Patients BP, Health-related quality of life questionnaire, Symptom-Distress index for fatigue, headache and dizziness would be assessed along with Patient compliance and adverse events. If any adverse events have been reported then the information needs to be entered in the adverse event Initial Notification Form. During the Third visit (after 8 weeks), Patients BP, Health-related quality of life questionnaire, Symptom-Distress index for fatigue, headache and dizziness, Patient compliance and adverse events would be assessed along with Global assessment by Investigator and Patient. If any adverse events have been reported then the information needs to be entered in the Adverse event Initial Notification Form. Blood pressure monitoring: Each center will follow BP assessment with standardized mercury manometer or the calibrated android BP apparatus in the Sitting, Non-dominant arm, BP recording with 5 minutes rest in the sitting posture Average of 2 readings will be taken for baselines levels Simultaneously record pulse rate Record standing BP only in those with postural symptoms
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •?All CVD patients (prior MI, ACS, PCI, CABG) with hypertension OR ?All CVD patients (prior MI, ACS, PCI, CABG) with Uncontrolled hypertension (BP > 140/90 mmHg for hypertensive patients and BP > 130/80 mmHg for hypertensive patients with Diabetes or renal disease).
排除标准
- •?Not willing to provide written informed consent and comply with the protocol?Age below 18 years and above 65 years ?Secondary hypertension?Patients requiring concomitant anti-hypertensive medications other than angiotensin receptor blockers (ARBs) or Metoprolol ?Uncontrolled diabetes mellitus ?Baseline laboratory values outside the clinically acceptable limits ?Pregnant women and lactating mothers ?Females of child bearing age not practicing contraception or not willing to use barrier contraceptive ?Known hypersensitivity to Olmesartan/Metoprolol?Patients with effort angina more than class II (Drugs like Nitrates, ranolazine or Trimetazidine can be used but not amlodipine or nicorandil).?Sick sinus syndrome or Atrioventricular block or Heart Failure.
结局指标
主要结局
Magnitude of systolic and diastolic blood pressure reduction from baseline at end of 8 weeks of treatment
时间窗: End of 8 weeks of treatment
Percent of subjects reaching blood pressure target of 140/90 mmHg in hypertensive patients and 130/80mmHg in hypertensive patients with diabetes and renal disease at end of 8 weeks of treatment
时间窗: End of 8 weeks of treatment
次要结局
未报告次要终点