CTRI/2020/07/026634RecruitingPhase 4
A post marketing, multicentre, single-arm, prospective clinical trial to assess the safety and efficacy of FDC of Propranolol Hydrochloride IP Plus Clonazepam IP Tablets in patients with anxiety disorders.â??
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Pms
Eligibility Criteria
Inclusion Criteria
- •1. Male or female patients age 18 - 65 years.
- •2. Primary diagnosis of generalized anxiety disorder (GAD) either moderate or severe as per
- •Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) as confirmed by the
- •MINI at Screening, in addition to a psychiatric evaluation by a board- certified or Biohavenapproved
- •board-eligible
- •psychiatrist;
- •>= 1 year
- •3. Hamilton Anxiety Scale (HAM-A) score at least 14.
- •4. Determined by the investigator to be medically stable at baseline/randomization as assessed by
- •medical history, physical examination, laboratory test results, and electrocardiogram testing.
- •Subjects must be physically able and expected to complete the trial as designed.
- •5. Literate and can understand and sign informed consent.
- •6. Women of childbearing potential must have a negative serum pregnancy test at screening and a
- •negative urine pregnancy test prior to dosing at Baseline.
Exclusion Criteria
- •1. Pregnant and lactating female patients.
- •2. Hypersensitivity and/or skin reactions to drug constituents
- •3. Patients with congestive heart failure
- •4. Patients with bronchospastic lung disease, or severe respiratory insufficiency
- •5. Patients planned to be undergoing any major surgery
- •6. Patients with diabetes and specifically prone to hypoglycaemia
- •7. Patients with a history of hypothyroidism
- •8. Wolf-Parkinson-White Syndrome and tachycardia
- •9. Patients with impaired hepatic or renal function
- •10. Patients with sleep apnoea, myasthenia gravis and narrow-angle glaucoma.
- •11. Patients using any of the prohibited medications:
- •a) Opioids) Use of alcohol/CNS depressants
- •c) Antiepileptic drugs phenytoin, phenobarbital, carbamazepine, lamotrigine and
- •d) drugs that have an effect on CYP2D6, 1A2, or 2C19 metabolic pathways
- •e) Cardiovascular drugs: antiarrhythmics, Digitalis Glycosides, Calcium Channel Blockers,
- •ACE Inhibitors, Alpha Blockers, Reserpine, inotropic agents, Isoproterenol and
- •Dobutamine,
- •f) Nonsteroidal Anti-Inflammatory Drugs, Antidepressants, Anesthetic Agents, Warfarin,
- •Neuroleptic Drugs, Thyroxine.
Investigators
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