Post-Marketing Surveillance of MICAMLO Combination Tablets on the Long-term Use

• Register: ClinicalTrials.gov
• Last refreshed on: 8 April 2013
• Main ID: NCT01353274
• Date of registration: 09/05/2011
• Primary sponsor: Boehringer Ingelheim Pharmaceuticals
• Public title: Post-Marketing Surveillance of MICAMLO Combination Tablets on the Long-term Use
• Scientific title: Post-Marketing Surveillance of MICAMLO Combination Tablets on the Long-term Use
• Date of first enrolment: May 2011
• Target sample size: 1000
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01353274
• Study type: Observational
• Study design: Observational Model: Case-Only, Time Perspective: Prospective

Countries of recruitment

Japan

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion criteria:

- Male and Female patients with hypertension who did not receive of MICAMLO Combination
Tablets AP before the start of the study

Exclusion criteria:

- Patients with a history of hypersensitivity to any ingredient of Micamlo Combination
Tablets AP and dihydropyridine derivatives

- Pregnant woman or possibly pregnant woman

- Patients with extremely poor bile secretion or patients with serious hepatic disorder



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Drug: Micamlo

Primary Outcome(s)

Causal relationship of adverse event [Time Frame: 1 year]

The Intensity of adverse event [Time Frame: 1 year]

Secondary Outcome(s)

The changes between baseline and observation period in blood pressure [Time Frame: baseline to 1 year]

Secondary ID(s)

1235.38

Source(s) of Monetary Support

Please refer to primary and secondary sponsors