Post-Marketing Surveillance of Micombi Tablets Survey on the Long-term Use

Completed

• Conditions: Hypertension
• Interventions: Drug: Telmisartan 40mg; Drug: Telmisartan 80mg; Drug: Hydrochlorothiazide 12.5mg

• Registration Number: NCT01050062
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The survey is conducted to collect safety and effectiveness information in Hypertensive patients treated with Micombi Tablets on the long term use in daily clinical settings in Japan.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-24
• Study Start: 2010-01
• Study First Submitted QC: 2010-01-14
• Study First Posted: 2010-01-15
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2012-12-18
• Results First Submitted QC: 2012-12-18
• Results First Posted: 2013-01-30
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-04
• Last Update Posted: 2014-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1452

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Micombi® Combination Tablet AP	Telmisartan 40mg	-
Micombi® Combination Tablet AP	Hydrochlorothiazide 12.5mg	-
Micombi® Combination Tablet BP	Telmisartan 80mg	-
Micombi® Combination Tablet BP	Hydrochlorothiazide 12.5mg	-

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs)	Week 52	The number of patient with any AEs, patients with drug-related AEs

Secondary Outcome Measures

Name	Time	Method
Systolic Blood Pressure (SBP)	Week 0 and Week 52	SBP is observed at Week 0 and Week 52. The change of SBP from Week 0 to Week 52 is calculated.
Diastolic Blood Pressure (DBP)	Week 0 and Week 52	DBP is observed at Week 0 and Week 52. The change of DBP from Week 0 to Week 52 is calculated.
Target Blood Pressure Achievement Rate	Week 52	The proportion of the patients with target blood pressure in 52 weeks administrative period. Target blood pressure is defined as 'Guidelines for the management of hypertension (JSH2009)': less than 140/90 (SBP/DBP) mmHg for \>= 65 years old or cerebrovascular disorder patient; less than 130/80 in diabetes, chronic kidney disease or myocardial infarction patient; less than 130/85 mmHg for others patient.
Blood Pressure Normalised Rate	Week 52	The proportion of the patients with normalized blood pressure in 52 weeks on administrative period. Normalized blood pressure is defined less than 140/90 (SBP/DBP) mmHg according to JSH2009

Trial Locations

Locations (314)

Boehringer Ingelheim Investigational Site 111; 🇯🇵 Ageo, Japan

Boehringer Ingelheim Investigational Site 209; 🇯🇵 Aisho-cho, Japan

Boehringer Ingelheim Investigational Site 22; 🇯🇵 Aizubange-machi, Japan

Boehringer Ingelheim Investigational Site 234; 🇯🇵 Akashi, Japan

Boehringer Ingelheim Investigational Site 78; 🇯🇵 Akiruno, Japan

Boehringer Ingelheim Investigational Site 79; 🇯🇵 Akishima, Japan

Boehringer Ingelheim Investigational Site 235; 🇯🇵 Ako, Japan

Boehringer Ingelheim Investigational Site 288; 🇯🇵 Akune, Japan

Boehringer Ingelheim Investigational Site 236; 🇯🇵 Amagasaki, Japan

Boehringer Ingelheim Investigational Site 237; 🇯🇵 Amagasaki, Japan

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