Phase 3
Completed N=305
A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient
Source: ClinicalTrials.gov NCT00415623 ↗Enrolled (actual)
305
Serious AEs
—
Results posted
Dec 2008
Primary outcomePrimary: Change in Systolic Blood Pressure (SBP) From Baseline to Week 8 — -7.0; -13.7 mmHg — p=<0.001
Summary
The changes in the trough systolic blood pressure from the baseline were assessed after 8 weeks of double-blind treatment with amlodipine 10 mg or amlodipine 5 mg
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Systolic Blood Pressure (SBP) From Baseline to Week 8 |
-7.0; -13.7 | <0.001 sig |
| SECONDARY Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8 |
-2.7; -6.8 | <0.001 sig |
| SECONDARY Combined Mean Change in SBP From Baseline to Week 6 and Week 8 (Mean by Patient) |
-6.8; -13.9 | <0.001 sig |
| SECONDARY Combined Mean Change in DBP From Baseline to Week 6 and Week 8 (Mean by Patient) |
-2.5; -6.5 | <0.001 sig |
| SECONDARY Number of Subjects Achieving the Target Blood Pressure Reduction Value at Week 8 |
43; 66 | 0.002 sig |
| SECONDARY Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value at Both Weeks 6 and 8 |
22; 52 | <0.001 sig |
| SECONDARY Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Week 8 |
35; 61 | 0.001 sig |
| SECONDARY Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Both Weeks 6 and 8 |
16; 44 | <0.001 sig |
| SECONDARY Trough Plasma Concentrations of Amlodipine -Amlodipine 5 mg |
7.02; 6.83; 7.03 | — |
| SECONDARY Trough Plasma Concentrations of Amlodipine -Amlodipine 10 mg |
7.18; 16.9; 16.9 | — |
Eligibility Criteria
Inclusion Criteria
- Untreated Hypertensive Patients: An systolic blood pressure of >=160 mmHg or diastolic blood pressure >=100mmHg.
- Treated Hypertensive Patients: An systolic blood pressure of >=140 mmHg or diastolic blood pressure of >= 90 mmHg.
- Patients with insufficient response to 5 mg of amlodipine in the screening period:Two successive systolic blood pressure measurements at Visit 4 (Week -2) and Visit 5 (Week 0 = baseline) >=140 mmHg
- Patients with a screening treatment compliance rate >= 80%
Exclusion Criteria
- Subjects with secondary hypertension (renal disease, pheochromocytoma, and Cushing's syndrome, etc.), severe hypertension (systolic blood pressure of 180 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher), and malignant hypertension
Data sourced from ClinicalTrials.gov (NCT00415623). 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.