To compare the efficacy and safety of a new formulation of telmisartan with the currently available formulation in the management of patients with type 2 diabetes and hypertensio

Phase 4

Completed

• Conditions: Health Condition 1: null- Diabetic Hypertension

• Registration Number: CTRI/2008/091/000248
• Lead Sponsor: Troikaa Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Adult patients aged 18-65 years.

2.Diabetic with FPG >= 126 mg/dl (7.0 mmol/l)

3.Patients with Stage I hypertension (JNC 7 guidelines)

4.Newly diagnosed treatment naïve/ currently untreated hypertension or patients unable to tolerate current antihypertensive therapy.

Exclusion Criteria

1.Age below 18 years and above 65 years
2.Stage 2 hypertension (JNC 7 guidelines)
3.Secondary hypertension
4.Any acute medical condition
5.Uncontrolled diabetes mellitus
6.Baseline laboratory values outside the clinically acceptable limits
7.Pregnant women and lactating mothers
8.Females of child bearing age not practicing contraception or not willing to use barrier contraceptive
9.Patients or relatives unwilling to give written informed consent
10.Participation in a clinical study involving an investigational product within past 30 days.
11.Known hypersensitivity to telmisartan/ ARB or any component of the formulations.

Study & Design

• Study Type: Interventional
• Study Design: Not specified