A clinical study to test the safety and the efficacy of a single-pill combination of 2 antihypertensive and 1 lipid-lowering drug in patients already well treated with the concomitant administration of the same three drugs on separate tablets
| ISRCTN | ISRCTN27159806 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27159806 |
| Secondary identifying numbers | CL3-05153-008 |
- Submission date
- 06/12/2017
- Registration date
- 02/02/2018
- Last edited
- 16/11/2018
- 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
Not provided at time of registration and not expected to be available in the future
Contact information
Dr Hoang Hai Nguyen
Scientific
Scientific
01 No Trang Long, Binh Thanh Dist
Ho Chi Minh
70000
Viet Nam
Study information
| Study design | Open-label randomized prospective local multicenter study |
|---|---|
| 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 the contact details to request a patient information sheet |
| Scientific title | An open label study to assess the safety and efficacy of Atorvastatin/Amlodipine/Perindopril fixed-dose combination in adult patients, following four weeks of adequate treatment with atorvastatin, amlodipine and perindopril given concurrently |
| Study hypothesis | To assess the safety and efficacy of Atorvastatin/Amlodipine/Perindopril fixed-dose combination in adult patients. |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Condition | Hypertension and dyslipidemia |
| Intervention | A total of 130 patients were included and randomized in a 1:1 ratio to one of the 2 free combination treatment dosage for 4 weeks: 1. Atorvastatin 10 mg, Amlodipine 5 mg and Perindopril 5 mg 2. Atorvastatin 20 mg, Amlodipine 5 mg and Perindopril 5 mg At Visit 2 (Week 4): Patients with blood pressure control were switched from their current free combination to the fixed-dose combination at the same dose levels. Patients with uncontrolled BP were up-titrated to: Atorvastatin/Amlodipine/Perindopril FDC 20/5/10 mg At Visit 3 (Week 8), any patient who is using either Atorvastatin/Amlodipine/Perindopril FDC 20/5/5 mg or 10/5/5 mg and having 140 mmHg ≤ SBP < 160 mmHg or 90 mmHg ≤ DBP < 100 mmHg, will also be up-titrated to Atorvastatin/Amlodipine/Perindopril 20/5/10 mg. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Atorvastatin, amlodipine, perindopril |
| Primary outcome measure | Safety: the number and percentage of patients reporting at least one adverse event during the usage of either Fixed Dose Combination 10/5/5 or 20/5/5; or 20/5/10 mg W4 to W12 Efficacy: the percentage of patients who, after 8 weeks of the FDC treatment with 10/5/5 or 20/5/5 strengths, maintained the BP (office-based measurement) <140/90 mmHg and were previously treated with the free combination of atorvastatin, amlodipine, and perindopril, given concurrently at the same dose level as in the combination and controlled on the blood pressure after 4 weeks of treatment with the free combination W4 to W12 By automatic device at office |
| Secondary outcome measures | 1. Safety: the number and percentage of patients reporting at least one adverse event during the usage of either free combination 10+5+5 or 20+5+5 mg 2. Inclusion to W4/premature withdrawal 3. Efficacy: 3.1. Change in SBP and DBP from baseline (Week 0) to Week 12 for patients having same dosage of Atorvastatin, Amlodipine and Perindopril 3.2. Percentage and absolute change in LDL-C from baseline (Week 0) to Week 12 for patients having same dosage of Atorvastatin, Amlodipine and Perindopril, and percentage of patients maintaining or achieving LDL-c target (<100 mg/dL) (all groups) 3.3. The percentage of patients who, after 4 or 8 weeks of FDC treatment with 20/5/10 mg strength, achieved the BP (office-based measurement) <140/90 mmHg |
| Overall study start date | 17/07/2015 |
| Overall study end date | 13/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 130 patients randomized |
| Participant inclusion criteria | 1. Confirmed inadequate BP control before study drug dispensing: for combined systolic and diastolic hypertension 2. Confirmed LDL-C value by the laboratory test performed at Selection visit 3. Patients who provide written informed consent to participate in the study 4. Outpatients of 18 years of age or above (male and female) |
| Participant exclusion criteria | 1. Known symptomatic orthostatic hypotension 2. Malignant hypertension 3. Secondary hypertension 4. Isolated diastolic hypertension 5. History of hypertension 6. Known diabetes mellitus type I or type II 7. History or current presence of lymphedema or leg edema (unilateral or bilateral) of venous origin 8. Presence of severe rhythm or conduction disorder 9. Any history of heart failure, New York Heart Association (NYHA) classification III or IV 10. Patients with contra-indications to statins, especially to Atorvastatin 11. Patients with contra-indications to calcium channel inhibitors, especially to Amlodipine 12. Patients with contra-indications to ACE inhibitors, especially to Perindopril arginine: 13. History of myopathy, familial history of hereditary muscular disorders |
| Recruitment start date | 19/04/2016 |
| Recruitment end date | 14/09/2016 |
Locations
Countries of recruitment
- Viet Nam
Study participating centres
Gia Dinh People’s Hospital
700000
Viet Nam
Viet Nam
Thong Nhat Hospital
700000
Viet Nam
Viet Nam
Tam Duc Heart Hospital
700000
Viet Nam
Viet Nam
Bach Mai Hospital
100000
Viet Nam
Viet Nam
National Geriatrics Hospital
100000
Viet Nam
Viet Nam
Sponsor information
Institut de Recherche Internationales Servier
Industry
Industry
50, rue Carnot
Suresnes
92284
France
| Website | http://www.servier.com/ |
|---|---|
"ROR" |
https://ror.org/034e7c066 |
Funders
Funder type
Industry
ADIR
No information available
Results and Publications
| Intention to publish date | 13/06/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Summary results will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study. The results will be published in scientific literature within 18 months after the end of the study. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com/ after the Marketing Authorisation has been granted. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No |
Editorial Notes
16/11/2018: Publication citation added.
03/07/2018: Link to basic results added.
