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

NCT01080742 | Completed

• 1 other identifier: EMR 200006-510
• Study Type: observational
• Target: 1,007
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

Hypertension; Lodoz; Bisoprolol; Hydrochlorothiazide

Outcome Measures

Primary Outcomes (1)

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

  Baseline and until 6 months of treatment

Secondary Outcomes (3)

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

  After 3 and 6 months of treatment

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

  After 3 and 6 months of treatment

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

  After 3 and 6 months of treatment

Interventions

Lodoz (Combination of bisoprolol and hydrochlorothiazide) DRUG

The investigator will decide in advance the best therapeutic strategy for each subject according to current practice, regardless of the potential participation of this subject in the study.

Also known as: Lodoz

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Residents of Thailand diagnosed with mild to moderate essential hypertension.

You may qualify if:

• Signed written informed consent
• Subjects diagnosed with mild to moderate essential hypertension
• Subjects foreseen for Lodoz treatment for hypertension
• Age ≥ 18 years

You may not qualify if:

• Subjects treated with Lodoz before study initiation
• Subjects who are pregnant
• Subjects with any known contraindications to Lodoz based on local label

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Thammasat Heart Center, Thammasat University Hospital

Pathum Thani, 12120, Thailand

Location

MeSH Terms

Conditions

Hypertension

Interventions

Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Dilok Piyayotai, MD

  Thammasat Heart Center, Thammasat University Hospital, 95 Moo 1, Klong Nueng, Klong Luang, Pathumthani 12120, Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2010
• First Posted: March 4, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 5, 2014

Record last verified: 2012-06

Locations

TH (1)