observational study in patients with blood pressure

Phase 4

Completed

• Conditions: Health Condition 1: I10- Essential (primary) hypertensionHealth Condition 2: null- Male and female treatment naïve patients, aged 18â??80 years, with diagnosis of Stage II essential hypertension (DBP 100â??114 mm Hg and SBP 160â??199mm Hg)

• Registration Number: CTRI/2018/02/011727
• Lead Sponsor: Dr Reddys Laboratories Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-05-10
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 600

Inclusion Criteria

1. Male and female treatment naïve patients, aged 18â??80 years, with diagnosis of Stage II essential hypertension (DBP 100â??114 mm Hg and SBP 160â??199mm Hg) at entry, who are considered appropriate for initial dual therapy with Telmisartan 80 mg+ Amlodipine 5mg/ 10 mg

2. Patients who have inadequate blood pressure control (DBP >90 mm Hg) but have shown atleast 2 mm DBP reduction after 4 weeks of dual therapy will be selected for treatment allocation of triple therapy or dual therapy

NOTE â??patients with initial DBP of 100-109mmHg generally initiated on telmisartan 80 mg + Amlodipine 5mg and those with DBP 110-114 mm Hg initiated on telmisartan 80 Mg + amlodipine 10mg.

Exclusion Criteria

1. Patients already taking antihypertensive drugs at screening (since the study is intended to enroll treatment naïve patients)

2.Patients not ready to refrain from taking treatment with other drugs that could interfere with the evaluation of efficacy and tolerability.

3.Patients with secondary hypertension (eg. due to renal artery stenosis etc.)

4.Patients with uncontrolled diabetes mellitus, significant cardiovascular or cerebrovascular disease [congestive heart failure (New York Heart Association class III/IV); unstable angina in the previous 3 months; stroke within the previous 6 months; myocardial infarction, cardiac surgery, or percutaneous transluminal coronary angiography in the previous 3 months; cardiac arrhythmia; cardiomyopathy; aortic or mitral valve stenosis]

5.Patients with renal or hepatic disease (based on known history or lab abnormalities) or serum electrolyte abnormalities

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in mean Seated trough DBP (Week 12)Timepoint: Change from baseline in mean Seated trough DBP (Week 12)

Secondary Outcome Measures

Name	Time	Method
Change from baseline in <br/ ><br>ï?· Mean Seated trough SBP (Week 12) <br/ ><br>ï?· Mean standing trough SBP (Week 12) <br/ ><br>ï?· Mean standing trough DBP (Week 12) <br/ ><br>Responder Rate (Week 12) A normalized blood pressure response defined as SBP140 mm Hg and DBP90 mm Hg, an optimal blood pressure response defined as SBP130mm Hg and DBP 80 mm Hg, and a DBP response defined as DBP90 mm Hg.Timepoint: week 12