A Multicentric Randomized Double Blind Double Dummy Parallel Group Comparative Phase III Clinical Study to Evaluate the Efficacy Safety & Tolerability

Phase 3

Not yet recruiting

• Conditions: Secondary hypertension, unspecified,

• Registration Number: CTRI/2022/09/046074
• Lead Sponsor: Ajanta Pharma Limited

Brief Summary

A Multicentric,Randomized, Double Blind, Double Dummy, Parallel Group, Comparative, Phase IIIClinical Study to Evaluate the Efficacy, Safety & Tolerability of FDC ofMetoprolol succinate 50/50 mg + Amlodipine 5/5 mg + Chlorthalidone 6.25/12.5 mgTablets versus Co-administration of Metoprolol succinate 50 mg and Amlodipine10 mg Tablets for patients with Uncontrolled Essential Hypertension. 

Trial of 84 days with two arms

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-10
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

• 1.Male or female subjects aged between 18 and 75 years (both inclusive).
• 2.Subjects those who are uncontrolled on FDC of Metoprolol succinate 50 mg + Amlodipine 5 mg.
• 3.Subjects with the history of uncontrolled essential hypertension [having seated diastolic BP (SeDBP) 90 to 110 mmHg and seated systolic BP (SeSBP) 140 to 180 mmHg] who is on the stable dose of two antihypertensive medications in recommended dose for atleast 4 weeks.
• 4.As judged by the Investigator, based on a clinical evaluation performed during the screening period.
• 5.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
• 6.Female subjects of childbearing potential must be willing to use acceptable method of contraception or post-menopausal for at least one year or surgically sterile.

Exclusion Criteria

• Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
• Subjects with EF <40% as per Simpson’s method on 2D Echo.
• Subjects diagnosed with Secondary or Malignant Hypertension.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in SeSBP between baseline and 12 weeks.	Mean change in SeSBP between baseline and 12 weeks. | The assessment of safety of subjects [comparison of incidence of treatment emergent adverse event (TEAE)
The assessment of safety of subjects [comparison of incidence of treatment emergent adverse event (TEAE)	Mean change in SeSBP between baseline and 12 weeks. | The assessment of safety of subjects [comparison of incidence of treatment emergent adverse event (TEAE)

Secondary Outcome Measures

Name	Time	Method
Mean change in SeDBP from baseline [Time frame: 4, 8 and 12 weeks].	Mean change in SeSBP from baseline [Time frame: 4, 8 and 12 weeks].

Trial Locations

Locations (12)

Aartham Multi Super Speciality Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Dr.Ram Manohar Lohia Institute of Medical Sciences; 🇮🇳 Lucknow, UTTAR PRADESH, India

Government Medical College and Govt General Hospital; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

GSVM Medical College; 🇮🇳 Dehat, UTTAR PRADESH, India

IPGME & R SSKM Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Jawahar Lal Nehru Medical College; 🇮🇳 Ajmer, RAJASTHAN, India

KHIMS Hospital; 🇮🇳 Dehat, UTTAR PRADESH, India

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Lifeline Multispeciality Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Medical college and hospital; 🇮🇳 Kolkata, WEST BENGAL, India

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Aartham Multi Super Speciality Hospital

🇮🇳Ahmadabad, GUJARAT, India

Dr Kuntal Shah

Principal investigator

8980075065

kuntalshah64@gmail.com