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CTRI Number  CTRI/2012/02/002428 [Registered on: 16/02/2012] Trial Registered Prospectively
Last Modified On: 29/05/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Rosuvastatin with Amlodipine for hypertension in Dyslipidemic Patients. 
Scientific Title of Study   A Multicentre, Comparative, Controlled, Open Label, Randomized, Parallel Group, Phase III Study to Evaluate the Safety and Efficacy of Fixed Dose Combination Containing Rosuvastatin Calcium with Amlodipine Besylate versus Monotherapy for Stage 1 and Stage 2 Hypertension in Dyslipidemic Patients. 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
G7SYN/P-001/2010, Version 3.0 dated 22 Nov 2011  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vanita Sabhahit 
Designation  Manager, Clinical Operations and Medical Affairs 
Affiliation  Biocon Limited 
Address  Biocon Limited, 20th KM, Hosur Road, Electronics City, Bangalore

Bangalore
KARNATAKA
560100
India 
Phone  080-28087513  
Fax    
Email  vanita.sabhahit@biocon.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vanita Sabhahit 
Designation  Manager, Clinical Operations and Medical Affairs 
Affiliation   
Address  Biocon Limited, 20th KM, Hosur Road, Electronics City, Bangalore


KARNATAKA
560100
India 
Phone  080-28087513  
Fax    
Email  vanita.sabhahit@biocon.com  
 
Details of Contact Person
Public Query  
Name  Dr Vanita Sabhahit 
Designation  Manager, Clinical Operations and Medical Affairs 
Affiliation   
Address  Biocon Limited, 20th KM, Hosur Road, Electronics City, Bangalore


KARNATAKA
560100
India 
Phone  080-28087513  
Fax    
Email  vanita.sabhahit@biocon.com  
 
Source of Monetary or Material Support  
Biocon Limited 
 
Primary Sponsor  
Name  Biocon Limited 
Address  20th KM, Hosur Road, Electronics City, Bangalore, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neeta Deshpande  Belgaum Diabetic Center  Ground Floor, Maruti Galli, Belgaum-590001
Belgaum
KARNATAKA 		 09880271313

neetarohit@gmail.com 
Dr Bindumathi P L  Dr. B.R.Ambedkar Medical College  Department of Medicine, 24, Kadugondanahalli, Bangalore-560045
Bangalore
KARNATAKA 		 09448134898

drbinduraghu@gmail.com 
Dr V A Kothiwale  Jawaharlal Nehru Medical College and KLES Dr Prabhakar kore Hospital and Medical research centre  Department of Medicine, Nehru Nagar, Belgaum-590010
Belgaum
KARNATAKA 		 09448119899

nov10kothiwale@yahoo.co.in 
Dr Vedavathi  KIMS Hospital  Department of Medicine, K.R.Road, V.V.Puram, Bangalore-04
Bangalore
KARNATAKA 		 09448683725

dr.vedavathikims@gmail.com 
Dr Mahesh Babu  Meenakshi Mission Hospital & Research Center  Dept. of Diabetology, OP no.102, Lake Area, Melur Road, Madurai - 625107
Madurai
TAMIL NADU 		 9486336110

crmb2004@yahoo.co.in 
Dr Balachandra G  Sapthagiri Institute of Medical Sciences and Research Center  No. 15, Chikkasandra, Hesaraghatta Road, Bangalore - 560090
Bangalore
KARNATAKA 		 9845111559

drgbalachandra@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ace Ethics  Approved 
Ethical Review Board, Meenakshi Mission Hospital and Research Center  Approved 
Institution Ethics Committee, Dr. B. R. Ambedkar Medical College & Hospital  Approved 
Institutional Ethics Committee, Kempegowda Institute of Medical Science  Approved 
Institutional Ethics Committee, KLE University  Approved 
Institutional Ethics Committee, Sapthagiri Institute of Medical Sciences & Research Center  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Stage 1 and Stage 2 Hypertension in Dyslipidemic Patients.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  FDC tablet of rosuvastatin calcium 10 mg + amlodipine besylate 10 mg  Administered orally once daily for 12 weeks 
Intervention  FDC tablet of rosuvastatin calcium 10 mg + amlodipine besylate 2.5 mg  Administered orally once daily for 12 weeks 
Intervention  FDC tablet of rosuvastatin calcium 10 mg + amlodipine besylate 5 mg  Administered orally once daily for 12 weeks 
Intervention  FDC tablet of rosuvastatin calcium 20 mg + amlodipine besylate 10 mg  Administered orally once daily for 12 weeks 
Intervention  FDC tablet of rosuvastatin calcium 20 mg + amlodipine besylate 2.5 mg  Administered orally once daily for 12 weeks 
Intervention  FDC tablet of rosuvastatin calcium 20 mg + amlodipine besylate 5 mg  Administered orally once daily for 12 weeks 
Intervention  FDC tablet of rosuvastatin calcium 5 mg + amlodipine besylate 10 mg  Administered orally once daily for 12 weeks 
Intervention  FDC tablet of rosuvastatin calcium 5 mg + amlodipine besylate 2.5 mg  Administered orally once daily for 12 weeks 
Intervention  FDC tablet of rosuvastatin calcium 5 mg + amlodipine besylate 5 mg  Administered orally once daily for 12 weeks 
Comparator Agent  Tablet amlodipine besylate 5 mg  Administered orally once daily for 12 weeks 
Comparator Agent  Tablet rosuvastatin calcium 10 mg  Administered orally once daily for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Patients willing to give informed consent
2.Male and female patients with stage 1 (SBP ≥140 mmHg / DBP ≥90 mm Hg- SBP 159mmHg / DBP 99 mm Hg) and stage 2 hypertension(SBP ≥160 mmHg / DBP ≥90 mm Hg- SBP 180mmHg / DBP ≥110 mm Hg
3.Border line high (LDL value between 130-159) and high dyslipidemic (LDL values between 160-189)
4.Subjects aged 18 years and above
5.Patients with hypertension who are on stable medication for at least 3 months, but their blood pressure is not adequately controlled
6.Hypertensive patients who are not taking treatment or taking irregular treatment, and hypertensive patients who are not responding to the treatment; but not on amlodipine besylate
7.Patients who are willing to comply with all study requirements
8.Females of childbearing potential should have a negative pregnancy test at the pre study visit and agree to use contraception during the study. 
 
ExclusionCriteria 
Details  1.Patients who are unlikely to comply with protocol requirements (e.g., non-cooperative behavior, inability to attend the required by the protocol visits).
2.Patients who are currently participating or had participated in other interventional study for last 3 months prior to their enrolment.
3.Known CVD, triglycerides 500 mg/dL, renal disease (serum creatinine levels 1.6 mg/dL), hypothyroidism, liver disease (ALT and/or AST levels 3-fold upper limit of normal in more than 2 consecutive measurements),
4.Alcohol consumption 3 drinks/day for men and 2 drinks/day for women, and current or previous gout.
5.Patients with HbA1c ≥ 9%
6.Patients who are positive for HIV test.
7.Patients currently taking lipid-lowering drugs other than statins.
8.Patients with abnormal Creatine Kinase (CK) level ( 2.5 times the upper normal limit).
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
•The percentage of reduction in systolic and/or diastolic blood pressure from baseline with fixed dose combination of rosuvastatin calcium (5/10/20 mg) with amlodipine besylate (2.5/5/10 mg) vs amlodipine besylate 5 mg monotherapy
•The percentage of reduction in LDL-C levels from baseline with fixed dose combination of rosuvastatin calcium (5/10/20 mg) with amlodipine besylate (2.5/5/10 mg) vs rosuvastatin calcium 10 mg monotherapy 		 12 weeks (84 days) of therapy 
 
Secondary Outcome  
Outcome  TimePoints 
•The percentage of patients treated with FDC of rosuvastatin calcium (5/10/20 mg) with amlodipine besylate (2.5/5/10 mg) vs monotherapy of amlodipine besylate 5mg, achieving recommended blood pressure levels
•The percentage of change in HDL-C, TC and fasting TG levels
•The percentage of patients treated with FDC of rosuvastatin calcium (5/10/20 mg) with amlodipine besylate (2.5/5/10 mg) vs. monotherapy of rosuvastatin calcium 10 mg, achieving LDL-C levels recommended by NCEP/ATP III 		 12 weeks (84 days) of therapy 
•Incidence of adverse events (AEs) and serious adverse events (SAEs) during the study period
•Clinically significant changes in vital signs.
•Clinically significant changes in routine laboratory parameters
•Clinical Significant changes in the ECG
 		 12 weeks 
 
Target Sample Size   Total Sample Size="330"
Sample Size from India="330" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   23/02/2012 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is a multicentre, randomized, parallel-group, open label study to compare the safety and efficacy of FDC containing rosuvastatin calcium and amlodipine besylate on stage 1 and stage 2 hypertension with dyslipidemic patients with that of monotherapy. There are 11 treatment arms planned for this study, 9 fixed dose combination arms of rosuvastatin calcium (5/10/20 mg/day) + amlodipine besylate (2.5/5/10 mg/day) and two monotherapy arms of rosuvastatin calcium (10 mg/day) and amlodipine besylate (5 mg/day). The study is planned to enroll a total of 330 patients; 30 patients in each arm.Patients will be stratified based on the SBP/DBP and LDL-C levels and randomized within each stratum with equal proportion to any of the treatment arms within the stratum.   
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