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

• Register: ISRCTN
• Last refreshed on: 13 May 2013
• Main ID: ISRCTN05051235
• Date of registration: 03/09/2010
• Primary sponsor: Libbs Pharmaceutical Ltd (Brazil)
• Public title: Comparative efficacy and safety of two formulations of ramipril combined with hydrochlorothiazide in mild to moderate hypertension LB0906
• Scientific title: Open, prospective, parallel, multicentre, randomized trial to evaluate the efficacy and safety of two ramipril 5mg+ hydrochlorothiazide 25 mg formulations (Naprix D® versus Triatec D®) in the treatment of mild to moderate hypertension
• Date of first enrolment: Dec 1 2010
• Target sample size: 130 patients
• Recruitment status: Completed/Not recruiting
• URL: http://isrctn.org/ISRCTN05051235
• Study type: Interventional
• Study design: Multicentre randomised open label prospective parallel group trial

Countries of recruitment

Brazil

Contacts

• Name: Debora Rodrigues

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Patients will be submitted to a two-week run-in phase, where their previous medication will be replaced by placebo. At the end of run-in phase, patients will be randomly allocated in one of the treatment groups, combined ramipril 5mg and hydrochlorothiazide 25mg in either pill or capsule form.
The duration of the treatment phase is 8 weeks, with two visits during this period (4 and 8 weeks).
Ambulatory blood pressure measurement (ABPM) will be performed at the end of the run-in and treatment phases.

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

LB0906

Source(s) of Monetary Support

Libbs Pharmaceutical Ltd (Brazil)

Secondary Sponsor(s)

N/A