A Clinical Trial to Evaluate the Safety and Efficacy of ZYH7 Compared to Fenofibrate in Patients With Dyslipidemia

October 25, 2013 updated by: Zydus Lifesciences Limited

A Multicentric Prospective Randomized Double Blind Parallel Group Active Controlled Study to Evaluate the Safety and Efficacy of ZYH7 Compared to Fenofibrate in Patients With Dyslipidemia

ZYH7, a novel peroxisome proliferator-activated receptor (PPAR) alpha agonist, is expected to decrease triglyceride level and also correct dyslipidemia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
109

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 160012
        • Room no 3027,Research block B,Department of Endocrinology PGIMER
    • Gujarat
      • Ahmedabad, Gujarat, India, 380007
        • Vijayratna Diabetes Diagnosis & Treatment Centre, Upper Ground Floor, Sumeru Centre, Nr Parimal Underbridge, Paldi
      • Ahmedabad, Gujarat, India, 380008
        • Devi Hospital,Ground floor, Naranpura
      • Ahmedabad, Gujarat, India, 380009
        • Private clinic, 4, Stadium House, Ground Floor, Navrangpura
      • Ahmedabad, Gujarat, India, 380015
        • Dia Care Reseach, 1&2- Gandhi Park Society, Nr. Nehrunagar Cross Roads, Ambawadi
      • Bhavnagar, Gujarat, India, 364001
        • Govt. Medical College, Bhavnagar
      • Rajkot, Gujarat, India, 360001
        • Gastrocare Clinic,Ground floor, Karansinhji Main Road,
      • Vadodara, Gujarat, India, 390 023
        • Balaji Hospital,First floor,clinical research department, Opp. Vidya Vikas School, Subhanpura,
    • Karnataka
      • Bangalore, Karnataka, India, 560 043
        • Pace Clinical Research (A. Unit of Pranav Diabetes Centre), No. 53, Nanda Complex, Ramamurthy Nagar Main Road, Banasawadi
      • Bangalore, Karnataka, India, 560085
        • Srinivasa clinic and Diabetic Care centre, 197, 2nd floor, Near Avalahalli BDA park, BSK 3rd stage
      • Davangere, Karnataka, India, 577002
        • Mallige Healthcare Centre, # 402, 8th main, 8th cross, Near Dr. M. C. Modi Compound. P.J.EXTN,
    • Maharashtra
      • Aurangabad, Maharashtra, India, 431001
        • Deogiri Diabetes Centre, 46 Samata Nagar, Near Kranti Chowk Police Station
      • Mumbai, Maharashtra, India, 400007
        • Bhatia Hospital, Tardeo Road,Room no 19, Basement floor,Research room,
      • Pune, Maharashtra, India, 411005
        • Pai Clinic & Diagnostic Centre - Abhinav Apartments, 778/B-4, First floor, Shivajinagar, Next to Congress House
    • Rajasthan
      • Jaipur, Rajasthan, India, 302024
        • Shree Nidan Hospital, Clinical trial department, First floor, 27-28 Vidhyut nagar-A, Ajmer road
    • Tamil Nadu
      • Vellore, Tamil Nadu, India, 632009
        • Mother's Care Diabetes Centre, Room no 9, Phase 1, Sathuvachari
    • Tamilnadu
      • Chennai, Tamilnadu, India, 600094
        • Aruna Diabetes Centre, 56,Thiruvengatapuram, Near Nungambakkam Railway Station, Choolamedu
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • Department of Endocrinology, Room No.9, 4 th Floor, Ronald Ross Building, Institute of Post Graduate Medical Education & Research, 244 AJC Bose Road.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18-65 years
  2. Subjects of either gender, males or females
  3. Triglycerides between 200 to 500 mg/dl on screening visit.
  4. Body mass index (BMI) > 23 kg/m2
  5. If subject is diabetic, he should be controlled on a maximum of two oral anti diabetic agents except Thiazolidinedione.
  6. Subject has given informed consent for participation in this trial.

Exclusion Criteria:

  1. Pregnancy and lactation.
  2. History of 5% weight loss in past 6 months.
  3. Subjects on treatment with insulin and PPAR alpha or gamma agonist in the past 3 month.
  4. Subjects having unstable angina, acute myocardial infarction in past 3 months or heart failure of New York Heart Association (NYHA) class (III-IV).
  5. Uncontrolled hypertension (150/100 mm of Hg).(If Subject using Thiazides, ACE inhibitors, beta blockers they should be on minimum 3 month stable therapy and treatment not expected to change during trial participation)
  6. History of clinically significant edema.
  7. History of pancreatitis or gall stone diseases.
  8. Subject having thyroid-stimulating hormone (TSH) levels outside normal reference range, Subjects who are clinically euthyroid and on stable thyroid replacement therapy for 2 months prior to screening and who are anticipated to remain on this dose throughout the trial period will be allowed.
  9. Uncontrolled diabetes (HbA1c ≥ 9 gm %).
  10. History of active liver disease or hepatic dysfunction demonstrated by aspartate aminotransferase (AST) and Alanine Aminotransferase(ALT) ≥ 2.5 times of upper normal limit (UNL) or bilirubin ≥ 2 times UNL in the past 3 months.
  11. Renal dysfunction demonstrated by abnormal Glomerular Filtration Rate (GFR) (60 ml/min) or presence of ketonuria.
  12. History of myopathies or evidence of active muscle diseases demonstrated by Creatinine Phosphokinase(CPK) ≥ 10 times UNL.
  13. History of any other concurrent serious illness (e.g. tuberculosis, Human Immunodeficiency Virus(HIV) infection, malignancy, etc).
  14. History of alcohol and/or drug abuse.
  15. History of known allergy, sensitivity or intolerance to the study drugs and their formulation ingredients.
  16. Subjects on any other lipid lowering medications. (Appendix I).
  17. If on contraceptive or hormone replacement therapy (HRT), therapy started or changed in last 3 months.
  18. Prolonged use of steroids (15 days) in last 3 months (topical preparations, nasal and intra-articular administration are permitted).
  19. History of long term use of non-steroidal anti-inflammatory drugs. (1 month)
  20. Participation in any other clinical trial in the past 3 months
  21. Unable to give informed consent and follow protocol requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: ZYH7 4mg
Drug: ZYH7
ZYH7 4mg given once orally in the morning before breakfast, for 8 weeks.
Drug: ZYH7
ZYH7 8 mg given once orally in the morning before breakfast, for 8 weeks.
Drug: ZYH7
ZYH7 16 mg given once orally in the morning before breakfast, for 8 weeks.
EXPERIMENTAL: ZYH7 8mg
Drug: ZYH7
ZYH7 4mg given once orally in the morning before breakfast, for 8 weeks.
Drug: ZYH7
ZYH7 8 mg given once orally in the morning before breakfast, for 8 weeks.
Drug: ZYH7
ZYH7 16 mg given once orally in the morning before breakfast, for 8 weeks.
EXPERIMENTAL: ZYH7 16mg
Drug: ZYH7
ZYH7 4mg given once orally in the morning before breakfast, for 8 weeks.
Drug: ZYH7
ZYH7 8 mg given once orally in the morning before breakfast, for 8 weeks.
Drug: ZYH7
ZYH7 16 mg given once orally in the morning before breakfast, for 8 weeks.
ACTIVE_COMPARATOR: Fenofibrate 160mg
Drug: Fenofibrate
Fenofibrate 160 mg given once orally in the morning before breakfast, for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage change in mean triglyceride level from baseline
Time Frame: 4 and 8 weeks
Percentage change in mean triglyceride levels from baseline within and across each treatment of ZYH7 The changes will be compared with fenofibrate 160mg.
4 and 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage change from baseline in lipid parameters
Time Frame: 4 and 8 weeks

Percentage change from baseline in the following lipid parameters:

  1. Low Density Lipoprotein Cholesterol(LDL)
  2. Very Low Density Lipoprotein Cholesterol (VLDL)
  3. High Density Lipoprotein (HDL)
  4. Total cholesterol
  5. Non HDL Cholesterol (Measured value)
  6. Apo A
  7. Apo B
  8. High sensitive C-Reactive Protein (hs-CRP)
4 and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zydus Lifesciences Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rajendra H Jani, Ph.D (Medical), Head & Senior Vice President, Clinical R&D, Cadila Healthcare Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZYH7.10.001.01
  • CTRI/2011/11/002147 (REGISTRY: Clinical Trials Registry - India)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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