A clinical trial to evaluate efficacy and safety of three drug combination ( telmisartan + hydrochlorthiazide + amlodipine ) in the treatment of patients suffering from essential hypertensio

Phase 3

Completed

• Conditions: Health Condition 1: null- Essential Hypertension

• Registration Number: CTRI/2010/091/001507
• Lead Sponsor: Dr Reddys Laboratories Ltd

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: 512

Inclusion Criteria

1.Patients of both sexes of age ≥ 18 years and ≤ 65 years

2.Patients with uncontrolled hypertension (SBP ≥ 140 mmHg and ≤ 179 mmHg; DBP ≥ 90 mmHg and ≤ 109 mmHg) when treated with full dose of monotherapy (Appendix III) or any of the combinations at the specified doses equipotent to or doses less potent than telmisartan 40 mg + Hydrochlorothiazide 12.5 mg given together (Appendix IV)

3.Non-diabetic patients or Type II diabetic patients with stabilized glycaemic control

4.Patients without CAD or patients with stable angina

Exclusion Criteria

1.Patients with Stage 2 hypertension with SBP ≥ 180 mmHg and DBP ≥ 110 mmHg
2.Patients with uncontrolled hypertension (SBP ≥ 140 mmHg and DBP ≥ 90 mmHg) when treated with doses of monotherapy, less than that mentioned in Appendix III
3.Patients with uncontrolled hypertension (SBP ≥ 140 mmHg and DBP ≥ 90 mmHg) when treated with any of the combinations at doses more potent than Telmisartan 40 mg + Hydrochlorothiazide 12.5 mg given together (doses higher than those given in appendix IV)
4.Patients with uncontrolled hypertension with combination containing beta blockers or three or more antihypertensive agents
5.Patients with history of unstable angina, myocardial infarction, Stroke, TIA or heart failure
6.Patients with history of moderate or malignant retinopathy, history of hypertensive encephalopathy, arrhythmias, sinus tachycardia or electrolyte imbalance
7.Patients with 2nd or 3rd degree heart block, clinically significant valvular heart disease
8.Patients with uncontrolled diabetes (HbA1c ≥ 9%)
9.Serum creatinine > 1.5 times the upper limit of normal (ULN)
10.Patients with history of hypersensitivity to any of the components of triple pill or sulphonamides
11.Patients with chronic inflammatory conditions, gouty arthritis or other conditions that require the continuous use of NSAIDs
12.Systemic Lupus Erythematosus
13.Acute medical conditions/ surgeries/ alcoholism
14.Medical/ psychiatric conditions likely to hinder trial process
15.Lactating and pregnant women.
16.Women of reproductive age, not practicing reliable contraception.
17.Hepatic dysfunction (AST/ALT/AlkPO4 > 3 times upper limit of normal/ Bilirubin > 1.5 times upper limit of normal (ULN)/ Known hepatic cirrhosis) or existing biliary obstruction

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ormalization of blood pressure (SBP 139 & DBP 89 mm Hg in non-diabetics and SBP 129 & DBP 79 mm Hg in diabetics) at the end of 8 weeks treatment period.Timepoint: Baseline and end of treatment ( 8 weeks)

Secondary Outcome Measures

Name	Time	Method
weeks. ? Change from baseline systolic blood pressure at the end of 8 weeks. ? Systolic blood pressure normalization (SBP â?¤ 139 mmHg in non-diabetics and SBP â?¤ 129 mm Hg in diabetics) or diastolic blood pressure normalization (DBP â?¤ 89 mmHg in non-diabetics and DBP â?¤ 79 mm Hg in diabetics) at the end of 8 weeks. ? Difference in BP responder rates at the end of 8 weeks as assessed by:Timepoint: Baseline and end of treatment ( 8 weeks)