Phase 3
Completed N=134
Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient
Source: ClinicalTrials.gov NCT00443456 ↗Enrolled (actual)
134
Serious AEs
6.0%
Results posted
Oct 2009
Primary outcomePrimary: Change in Systolic Blood Pressure From Baseline of the Preceding Study — 148.8; 148.8; 148.8; -8.7 mmHg
Summary
To investigate the safety and efficacy of the long-term use of amlodipine 10 mg in subjects who will be able to enter a long-term study after completing the parent study "A double-blind comparative study between amlodipine 5 mg and 10 mg in patients with essential hypertension for whom amlodipine 5 mg is insufficiently effective" (Protocol No.: A0531085).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Systolic Blood Pressure From Baseline of the Preceding Study |
148.8; 148.8; 148.8; -8.7; -5.6; -12.0 | — |
| PRIMARY Change in Systolic Blood Pressure From Baseline of This Long-term Study |
140.1; 143.2; 136.8; -6.0; -8.9; -3.0 | — |
| PRIMARY Change in Diastolic Blood Pressure From Baseline of the Preceding Study |
86.3; 87.6; 84.8; -3.1; -1.8; -4.5 | — |
| PRIMARY Change in Diastolic Blood Pressure From Baseline of This Long-term Study |
83.1; 85.8; 80.3; -3.3; -4.8; -1.7 | — |
| PRIMARY Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value |
41; 15; 26; 59; 27; 32 | — |
| PRIMARY Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study |
36; 13; 23; 55; 25; 30 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who had completed the preceding study A0531085, Phase III study, who the investigator judged to be able to further treatment of long term administration in terms of efficacy and safety
- Patients who had a treatment compliance rate of at least 80%
Exclusion Criteria
- The patient who met the discontinuation criteria in the preceding study A0531085
Data sourced from ClinicalTrials.gov (NCT00443456). 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.