Comparative efficacy and safety of two formulations of ramipril combined with hydrochlorothiazide in mild to moderate hypertensio

Completed

• Conditions: Hypertension; Circulatory System; Essential (primary) hypertension

• Registration Number: ISRCTN05051235
• Lead Sponsor: ibbs Pharmaceutical Ltd (Brazil)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-03
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

1. Both sex, adults (> 18 years)
2. Established essential hypertension, untreated or treated but uncontrolled with treatment:
2.1. Office systolic blood pressure (SBP) 160-179 mmHg and diastolic blood pressure (DBP) 100-109 mmHg for untreated patients or patients already treated with combination drug
2.2. Office SBP 140-159 mmHg and DBP 100-109 mmHg for non-controlled patients treated with monotherapy

Exclusion Criteria

1. Women of childbearing potential
2. Known hypersensitivity to drug study or angiotensin-converting enzyme inhibitors and/or diuretics
3. No-adhesion to treatment during run-in phase
4. Abnormal and clinically significant laboratory test results
5. Abnormal and clinically relevant ECG tracing
6. Pectoris Angina
7. Decompensate Congestive Heart Failure or that requires use of antagonists of renin-angiotesin-aldosteron system
8. Obesity with BMI over 35 kg/m2
9. Advanced or moderate hepatitis insufficiency
10. Decompensate or serious renal insufficiency. Creatinine clearance above 30 mL/min/1,73 m2
11. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease
12. Recent (< 6 months) or planned coronary revascularization
13. Cerebral vascular accident in the previous twelve months
14. Non controlled diabetes mellitus
15. Any serious or relevant disease at investigator criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in mean SBP and DPB as measured by ABPM from week 2 to week 10

Secondary Outcome Measures

Name	Time	Method
1. To assess the changes in BP during 24-h ABPM at 8 weeks<br>2. To assess mean change in SBP and DBP from baseline to study end at 8 weeks<br>3. To assess the responder rate at 8 weeks<br>4. To asses the mean change from study baseline in office BP following eight weeks of treatment<br>5. Adverse events, vital signs, laboratory tests