A clinical trial to study the efficacy, safety and tolerability of metoprolol + amlodipine in the treatment of hypertension.

ASSESSMENT OF THE EFFICACY AND TOLERABILITY OF A FIXED-DOSE COMBINATION OF METOPROLOL AND AMLODIPINE IN ESSENTIAL HYPERTENSION

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000269

Enrollment

100

Registered

2009-08-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: A fixed dose combination of amlodipine and metoprolol: 2 Strengths A)Amlodipine 5 mg+ Metoprolol extended release 25 mg B) Amlodipine 5 mg+ Metoprolol extended release 50 mg Treatment d

Eligibility

Inclusion criteria

Inclusion criteria: 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: &#8805; 140/90 mmHg & < 180/110mmHg. In isolated systolic hypertension, the blood pressure cut off for inclusion is SBP of &#8805;140.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Change in Blood Pressure at 4 and 8 weeks of therapy, compared to baselineTimepoint: 4th and 8th week	—

Secondary

Measure	Time frame
Proportion of patients achieving normalisation of BP as per JNC- VII guidelinesTimepoint: 8 weeks	—

Countries

India

Contacts

Public ContactDr Naveen Kumar

naveenkbr@drreddys040-30783246

Outcome results