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
- Conditions
- Hypertension and dyslipidemiaCirculatory System
- Registration Number
- ISRCTN27159806
- Lead Sponsor
- Institut de Recherche Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 130
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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<br><br> W4 to W12<br> 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<br><br> W4 to W12<br> By automatic device at office<br>
- Secondary Outcome Measures
Name Time Method <br> 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<br> 2. Inclusion to W4/premature withdrawal<br> 3. Efficacy:<br> 3.1. Change in SBP and DBP from baseline (Week 0) to Week 12 for patients having same dosage of Atorvastatin, Amlodipine and Perindopril<br> 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)<br> 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<br>