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

ISRCTN ISRCTN05051235
DOI https://doi.org/10.1186/ISRCTN05051235
Protocol serial number LB0906
Sponsor Libbs Pharmaceutical Ltd (Brazil)
Funder Libbs Pharmaceutical Ltd (Brazil)
Submission date
09/08/2010
Registration date
03/09/2010
Last edited
08/05/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Debora Rodrigues
Scientific

Rua Josef Kryss, 250
São Paulo
01140-050
Brazil

Study information

Primary study designInterventional
Study designMulticentre randomised open label prospective parallel group trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleOpen, 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
Study acronymLB0906
Study objectivesThis is study was designed to compare two dosage forms of combined ramipril (5mg) and hydrochlorothiazide (25mg) (capsule versus pills)
Ethics approval(s)The Ethical Committee of Federal University of Sao Paulo/Sao Paulo Hospital approved on July 23rd 2010
Health condition(s) or problem(s) studiedHypertension
InterventionPatients 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.
Intervention typeDrug
PhasePhase III
Drug / device / biological / vaccine name(s)Ramipril + hydrochlorothiazide (Naprix D® [capsule]; Triatec D® [pill])
Primary outcome measure(s)

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

Key secondary outcome measure(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

Completion date30/07/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration130
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/12/2010
Date of final enrolment30/07/2011

Locations

Countries of recruitment

  • Brazil

Study participating centre

Rua Josef Kryss, 250
São Paulo
01140-050
Brazil

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2013 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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