A clinical trial to study the efficacy, safety and tolerability of metoprolol + amlodipine in the treatment of hypertension.
- Registration Number
- CTRI/2009/091/000269
- Lead Sponsor
- Dr.Reddy's Laboratories Ltd,Ameerpet, Hyderabad-500016
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Patients of either sex aged between 18 to 75 with mild to moderate essential hypertension who are drug naïve or have
not shown response to dietary and lifestyle modification or previous therapy (if different from study drug regimen).
OR
Hypertensive Patients with CAD/ CAD equivalents.
The blood pressure cut offs for inclusion are: ≥ 140/90 mmHg & < 180/110mmHg.
In isolated systolic hypertension, the blood pressure cut off for inclusion is SBP of ≥140.
1)An absolute contraindication / intolerance or hypersensitivity reaction to any of the components in the combination
2) The physician is of the opinion that changing a patient's medication would put the patient at risk (e.g. high dose beta-blocker required to manage anginal symptoms or for rate control in atrial fibrillation, accelerated/ severe malignant hypertension, severe obstructive coronary artery disease, cardiac failure,
uncontrolled diabetes mellitus, severe renal insufficiency)
3) Recent (within 6 months) myocardial infarction or stroke
4) Acute medical conditions/ surgeries
5) Medical/ psychiatric conditions likely to hinder trial process
6) Pregnancy and lactation
7) Women of reproductive age, not practicing contraception.
8) Hepatic dysfunction (AST/ALT/AlkPO4) level more than 3 times upper limit of
normal/ Bilirubin greater than 1.5 times upper limit of normal (ULN)/ Known
hepatic cirrhosis)
9) Renal dysfunction (any of the renal function tests more than 3 times the upper
limit of normal)
10) Concurrent immunosuppressive or antineoplastic therapy
11) Drug or alcohol abuse
12) Treatment with another investigational drug of less than 30 days since prior to
therapy.
13) Prior enrolment in the same trial
14) Patients unwilling to give written informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method