Clinical trial NCT01613729: Efficacy and Safety Study of 5 mg and 10 mg Rosuvastatin
Official title: An Open-label, Randomized, Multi-centre, Phase IVb, Parallel Study Group to Compare the Efficacy and Safety of 5 mg and 10 mg Rosuvastatin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dyslipidemia
Keywords: Dyslipidemia
Rosuvastatin
Efficacy
Safety
Lead sponsor: D16 Pharma & Biotec Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: Dhaka Medical College
name: National Institute of Cardiovascular Diseases
First posted: 2012-06-07
Enrollment: 2000
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to compare the efficacy of Rosuvastatin 5 mg once daily with Rosuvastatin 10 mg once daily by assessment of the number of patients with hypercholesterolemia reaching the LDL-C target goal of \<100 mg/dL after 12 weeks of therapy.

Detailed description: This study will observe the followings:

1. To compare the effect of 5 mg/10 mg Rosuvastatin by assessment of the number of patients reaching LDL-C target goal after 24 weeks of therapy.
2. To compare the effect of 12 weeks therapy with 5 mg/10 mg Rosuvastatin on change in LDL-C (compare change from baseline).
3. To investigate the effect of 12 weeks therapy with 10 mg Rosuvastatin on change in LDL-C (compare values week 0 vs. week 12).
4. To investigate the safety of Rosuvastatin in regards to liver enzyme change, kidney function and muscle toxicity.
5. To compare the effect of 12 weeks therapy with 5 mg/10 mg Rosuvastatin on change in TC, HDL-C, TG, LDL-C density and HbA1c (compare change from baseline).
6. To investigate the effect of 12 weeks therapy with 10 mg Rosuvastatin on change in TC, HDL-C, TG, LDL-C density and HbA1c (compare values week 0 vs. week 12).
7. To investigate the effect of 12 weeks therapy on change in microalbuminuria in each treatment group (compare change from baseline).
8. To investigate the effect of 12 weeks therapy on change in BMI (compare change from baseline).

   The effects of the dose increase and the dose decrease from weeks 12 to 24 will be evaluated as follows:
9. To investigate the change in LDL-C by increasing the dose from 5 mg to 10 mg (compare values week 12 vs. 24).
10. To investigate the change in LDL-C by decreasing the dose from 10 mg to 5 mg (compare values week 12 vs. 24).
11. To investigate the change in TC, HDL-C, TG, LDL-C density and HbA1c by increasing the dose from 5 mg to 10 mg (compare values week 12 vs. 24).
12. To investigate the change in TC, HDL-C, TG, LDL-C density and HbA1c by decreasing the dose from 10 mg to 5 mg (compare values week 12 vs. 24).

Eligibility criteria: Inclusion Criteria:

* Age 45 - 75 years
* LDL - C between 130 mg/dL and 250 mg/dL
* TG \< 400 mg/dL
* HbA1c \< 7%
* Written informed consent to participate in the trial

Exclusion Criteria:

* Known hypersensitivity or history of SAE with another HMG-CoA reductase inhibitor, in particular any history of myopathy
* Active liver disease/severe hepatic impairment
* Treatment with cyclosporin or any disallowed drug
* Patients with unstable angina pectoris

Primary outcomes:
measure: Efficacy of Rosuvastatin 5 mg once daily with Rosuvastatin 10 mg once daily by assessment of the number of patients with hypercholesterolemia reaching the LDL-C target goal of <100 mg/dL after 12 weeks of therapy.
timeFrame: 24 weeks
Secondary outcomes:
measure: To compare the safety
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: BSMMU
Study officials:
affiliation: Professor of Cardiology
name: Nazrul Islam, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: D16 Pharma & Biotec
name: Pinaki Bhattacharya, MBBS
role: STUDY_DIRECTOR
References: