A clinical trial to study the efficacy and safety of combination drugs of chlorthalidone, metoprolol and telmisartan in treatment of high blood pressure with stable coronary artery disease.
- Conditions
- Health Condition 1: I10- Essential (primary) hypertension
- Registration Number
- CTRI/2016/11/007491
- Lead Sponsor
- Sun Pharma Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 254
Inclusion Criteria:
Subjects must meet all of the following criteria to be considered for
enrollment in the study:
1.Male or female patient aged between 18 and 65 years.
2.Patient of stable coronary artery disease (no change in severity of symptoms or nitrate consumption in previous 3 months)
3.Subject with uncontrolled essential hypertension [having seated diastolic BP (SeDBP) 90 to 110 mmHg and seated systolic BP (SeSBP) 140 to 200 mmHg] who is on the stable dose of fixed drug combination therapy of Metoprolol extended release (25/50 mg) + Telmisartan 40 mg for at least 4 weeks.
4.As judged by the Investigator, based on a medical evaluation performed during the screening period. The medical evaluation must include normal or non-clinically significant physical examination, laboratory examination and 12-lead ECG.
5.Patient willing to give informed consent.
6.Female subjects of childbearing potential must be willing to use acceptable method of contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilized, or has not had a hysterectomy at least three months prior to the start of this study. Acceptable method of contraception includes (e.g., barrier method with spermicide). The calendar method, withdrawal, or an IUD is NOT an acceptable method.
Exclusion Criteria:
Subjects meeting any of the following criteria must be excluded from
enrollment in the study:
1. Presence of any clinically relevant disease/disorder (e.g. severe hepatic impairment, chronic renal failure, thromboembolic disorders, coronary artery or cerebrovascular diseases, uncontrolled diabetes, uncontrolled thyroid disorder etc.)
2. Surgical or medical condition that, in the judgment of the Investigator or Sponsor, could interfere with absorption, distribution, metabolism, or excretion of the drugs to be used.
3. Presence or history of secondary or malignant hypertension.
4. Any known cardiac disease/disorder in which any of the study medication is contra-indicated (e.g. severe bradycardia, heart block greater than first degree or significant first degree block, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome without pacemaker etc.)
5. Current or recent substance abuse, including alcohol.
6. Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests.
7. Participation in any experimental drug study within 60 days before
screening.
8. Breast feeding or pregnant females or Females with child-bearing
potential who do not follow adequate contraceptive measures.
9. Concomitant or prior (within 60 days of screening) use of any of the following medications: calcium channel blocker, clonidine, aliskerin.
10. Subjects having intolerance, hypersensitivity or any other contraindication to any of the Investigational products.
11. History of HIV, Hepatitis B and Hepatitis C
12. Subjects judged unfit for this study by investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Endpoint(s) <br/ ><br>Primary Outcome measure(s) will be: <br/ ><br>â?¢Mean change in Seated Diastolic Blood Pressure (SeDBP) between baseline and 24 weeks [Time frame: Baseline, 24 weeks] <br/ ><br>â?¢Mean change in Seated Systolic Blood Pressure (SeSBP) between baseline and 24 weeks [Time frame: Baseline, 24 weeks] <br/ ><br>Timepoint: Baseline-24 weeks
- Secondary Outcome Measures
Name Time Method Efficacy evaluation: <br/ ><br>â?¢Mean change in Seated Diastolic Blood Pressure from baseline <br/ ><br>â?¢Mean change in Seated Systolic Blood Pressure from baseline <br/ ><br>â?¢Proportion of patients achieving SeDBP less than 90 mmHg (SeDBP responder) <br/ ><br>â?¢Proportion of patients achieving SeSBP less than 140 mmHg (SeSBP responder) <br/ ><br>â?¢Evaluation of CGI-S from baseline <br/ ><br>â?¢Evaluation of CGI-I <br/ ><br>Safety Evaluation: <br/ ><br>â?¢Adverse events <br/ ><br>Timepoint: Baseline-24 weeks