Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension

Official Title: “A 12-week Multicenter, Randomized, Double-blind, Parallel-group, Active-control Study to Evaluate the Antihypertensive Efficacy and Safety of Valsartan/Amlodipine-based Regimen Versus a Losartan-based Regimen in Patients With Stage 2 Systolic Hypertension”

This study will compare the antihypertensive efficacy and safety of a valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2 systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and less than 200 mmHg).

Intervention(s) in this Clinical Trial

• Drug: valsartan, amlodipine, HCTZ
  • combination Valsartan/amlodipine160/5 mg tablet for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (6 weeks) of the study
• Drug: Losartan, HCTZ followed by valsartan, amlodipine, HCTZ
  • losartan 100mg capsule for 3 weeks; losartan 100mg capsule +HCTZ 25 mg capsule for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (3 weeks) of the study

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Valsartan/amlodipine/HCTZ
  • Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
• Active Comparator: Losartan/HCTZ
  • Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.

Primary Measures

• Change in Mean Sitting Systolic Blood Pressure After 6 Weeks
  • Time Frame: Baseline to Week 6
    Safety Issue?: No

Secondary Measures

• Change in Mean Sitting Diastolic Blood Pressure After 6 Weeks
  • Time Frame: Baseline to Week 6
    Safety Issue?: No
• Cumulative Percentage of Patients Achieving Blood Pressure Control
  • Time Frame: 3 and 6 weeks
    Safety Issue?: No
• Cumulative Percentage of Treatment Responders
  • Time Frame: 3 and 6 weeks
    Safety Issue?: No
• Change in Mean Sitting Systolic and Diastolic Blood Pressure After 12 Weeks
  • Time Frame: Baseline to week 12
    Safety Issue?: No
• Cumulative Percentage of Patients With Incidence of Peripheral Edema Before or at the Corresponding Visit
  • Time Frame: 3, 6, 9 and 12 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Male or female outpatient of 18 years of age or greater
• Stage 2 systolic hypertension defined as office Mean Sitting Systolic blood pressure (MSSBP) greater than or equal to 160 and < 200 mmHg at randomization
• Patients who were able to participate in the study, and who gave written informed consent before any study assessment was performed.

Exclusion Criteria:

• Office systolic blood pressure >200 and/or mean sitting diastolic blood pressure (MSDBP) greater than or equal to 110 mmHg at Visit 1.
• Use of four (4) or more antihypertensive medications within 30 days of Visit 1.
• Refractory hypertension, defined as blood pressure >140/90 mmHg while taking three (3) drugs at the maximum dose of each drug, one of which must be a diuretic. (Therapy with a fixed-dose combination of two active medications represents two drugs).
• Inability to safely discontinue all antihypertensive medications for 1-2 weeks prior to randomization.
• Other protocol-defined inclusion/exclusion criteria may apply

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director 862-778-8300  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00931710

Study ID Number: CVEA489AUS01

ClinicalTrials.gov Identifier: NCT00931710

Health Authority: United States: Food and Drug Administration