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An Observational Study to Evaluate the Efficacy of Lodoz in a Population of Hypertensive Patients

Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Lodoz (Combination of bisoprolol and hydrochlorothiazide) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Merck KGaA

Official(s) and/or principal investigator(s):
Dilok Piyayotai, MD, Principal Investigator, Affiliation: Thammasat Heart Center, Thammasat University Hospital, 95 Moo 1, Klong Nueng, Klong Luang, Pathumthani 12120, Thailand

Summary

This is an observational, prospective, non-interventional, non-randomised, open label multicentric study planned to be conducted in 1000 subjects with mild to moderate primary hypertension in approximately 20 centres in Thailand. The purpose of this study is to examine the beneficial effects of combination of bisoprolol with hydrochlorothiazide available as Lodoz in treatment of Thai subjects with mild to moderate hypertension. The outcome of the study would also provide information on the optimal daily dosage schedule as well as adherence of Lodoz.

Clinical Details

Official title: A Prospective Observational Study to Evaluate the Efficacy of Lodoz in a Population of Hypertensive Patients

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Mean systolic blood pressure (SBP) reduction and mean diastolic blood pressure (DBP) reduction at month 3 and 6 from baseline

Secondary outcome:

Response rate for SBP (defined as ≥ 10 mm Hg or SBP < 140 mmHg)

Response rate for DBP (defined as ≥ 10 mm Hg or DBP < 90 mmHg)

Proportion of subjects having reached target BP level, regarding Thai Hypertension Society guideline

Detailed description: Essential hypertension is a heterogenous multifactorial disease affecting large number of population. Monotherapy treatment in hypertension is often unable to achieve the desired blood pressure (BP) goals and subjects even remain at significant risk for developing cardiovascular disease. The use of combination therapy as first line treatment for hypertension provides a solution to the management problems related to hypertension. Among combination drugs, low dose combinations are useful tools in treating large segments of hypertensive subjects because of their several advantages, such as simplified dosage regimens, improve compliance and hypertensive control, decrease dose dependent side effects as well as reduce costs. OBJECTIVES Primary objective:

- To evaluate the efficacy of Lodoz therapy when used in routine clinical practice in

subjects with mild to moderate essential hypertension. Secondary objective:

- To evaluate the discontinuation rate of Lodoz therapy.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Signed written informed consent

- Subjects diagnosed with mild to moderate essential hypertension

- Subjects foreseen for Lodoz treatment for hypertension

- Age ≥ 18 years

Exclusion Criteria:

- Subjects treated with Lodoz before study initiation

- Subjects who are pregnant

- Subjects with any known contraindications to Lodoz based on local label

Locations and Contacts

Thammasat Heart Center, Thammasat University Hospital, Pathumthani 12120, Thailand
Additional Information

Starting date: January 2010
Last updated: August 4, 2014

Page last updated: August 23, 2015

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