Condition category
Circulatory System
Date applied
09/08/2010
Date assigned
03/09/2010
Last edited
08/05/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Debora Rodrigues

ORCID ID

Contact details

Rua Josef Kryss
250
São Paulo
01140-050
Brazil

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 measures

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

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

Sponsor information

Organisation

Libbs Pharmaceutical Ltd (Brazil)

Sponsor details

c/o Debora Garcia Rodrigues
Rua Josef Kryss
250
São Paulo - São Paulo
01140-050
Brazil

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23623755

Publication citations

  1. 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.

Additional files

Editorial Notes