Phase 4
Completed N=233
Candesartan Effect in Second Stage Arterial Hypertension
Stage II Hypertension
Source: ClinicalTrials.gov NCT00621153 ↗
Enrolled (actual)
233
Serious AEs
—
Results posted
Mar 2010
Primary outcomePrimary: Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy — -17.0; -14.1 mmHg
Summary
To compare the changes in mean sitting DBP from baseline after 4 weeks of therapy with either candesartan cilexetil/HCT combination therapy or candesartan cilexetil monotherapy regimen
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy |
-17.0; -14.1 | — |
| SECONDARY Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy |
— | — |
| SECONDARY Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 4 Weeks of Therapy |
— | — |
| SECONDARY Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 8 Weeks of Therapy |
— | — |
| SECONDARY Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy |
— | — |
| SECONDARY Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy |
— | — |
| SECONDARY Occurrence of Adverse Events (AE) and Discontinuation of Study Medication Due to AE's From Baseline (Randomisation) to the End of the Study (8 Weeks) |
— | — |
| SECONDARY Compliance Levels at 4 Weeks and 8 Weeks of Therapy |
— | — |
Eligibility Criteria
Inclusion Criteria
- Stage II essential hypertension (SBP≥ 160 or DBP≥100 mmHg), untreated, or treated with a maximum of 2 class of antihypertensive drugs
Exclusion Criteria
- Current serum-creatinine >3 mg/dL, Current serum-potassium >5.5 mmol/L, 16.
- Pregnant or lactating women or women of childbearing potential who were not protected from pregnancy
Data sourced from ClinicalTrials.gov (NCT00621153). 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.