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 |
| Secondary identifying numbers | LB0906 |
- 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
Scientific
Rua Josef Kryss, 250
São Paulo
01140-050
Brazil
Study information
| Study design | Multicentre randomised open label prospective parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| 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 |
| Study acronym | LB0906 |
| Study objectives | This 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) studied | Hypertension |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Ramipril + hydrochlorothiazide (Naprix D® [capsule]; Triatec D® [pill]) |
| Primary outcome measure | Reduction in mean SBP and DPB as measured by ABPM from week 2 to week 10 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/12/2010 |
| Completion date | 30/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 130 patients |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2010 |
| Date of final enrolment | 30/07/2011 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Rua Josef Kryss, 250
São Paulo
01140-050
Brazil
01140-050
Brazil
Sponsor information
Libbs Pharmaceutical Ltd (Brazil)
Industry
Industry
c/o Debora Garcia Rodrigues
Rua Josef Kryss, 250
São Paulo - São Paulo
01140-050
Brazil
"ROR" |
https://ror.org/055kp8612 |
|---|
Funders
Funder type
Industry
Libbs Pharmaceutical Ltd (Brazil)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
