N/A
Completed N=1,157
Safety and Efficacy of Daily Use of Micamlo® Combination Tablets AP in Patients With Hypertension
Source: ClinicalTrials.gov NCT01353274 ↗Enrolled (actual)
1,157
Serious AEs
2.0%
Results posted
Aug 2014
Primary outcomePrimary: Incidence of Drug-related Adverse Events — 60 participants
Summary
Investigation of safety and efficacy of daily use of Micamlo Combination Tablets AP in patients with Hypertension
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Drug-related Adverse Events |
60 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) |
-15.9; -16.5; -16.7; -17.7; -19.2 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure (DBP) |
-7.6; -8.4; -8.2; -8.9; -9.8 | — |
| SECONDARY Proportion of Patients Who Achieved the Target BP |
54.2; 57.8; 58.8; 62.4; 66.5 | — |
| SECONDARY Proportion of Patients Who Normalised Their BP |
61.3; 66.3; 67.2; 70.4; 73.7 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01353274). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.