Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LB0906
Study information
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
Acronym
LB0906
Study hypothesis
This is study was designed to compare two dosage forms of combined ramipril (5mg) and hydrochlorothiazide (25mg) (capsule versus pills)
Ethics approval
The Ethical Committee of Federal University of Sao Paulo/Sao Paulo Hospital approved on July 23rd 2010
Study design
Multicentre randomised open label prospective parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
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
Phase
Phase III
Drug names
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 trial start date
01/12/2010
Overall trial end date
30/07/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
130 patients
Participant 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
Recruitment start date
01/12/2010
Recruitment end date
30/07/2011
Locations
Countries of recruitment
Brazil
Trial participating centre
Rua Josef Kryss, 250
São Paulo
01140-050
Brazil
Funders
Funder type
Industry
Funder name
Libbs Pharmaceutical Ltd (Brazil)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23623755
Publication citations
-
Results
Oigman W, Gomes MA, Pereira-Barretto AC, Póvoa R, Kohlmann O, Rocha JC, Nobre F, Efficacy and safety of two ramipril and hydrochlorothiazide fixed-dose combination formulations in adults with stage 1 or stage 2 arterial hypertension evaluated by using ABPM., Clin Ther, 2013, 35, 5, 702-710, doi: 10.1016/j.clinthera.2013.03.015.