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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00931710
First received: July 1, 2009
Last updated: March 1, 2011
Last verified: March 2011

July 1, 2009
March 1, 2011
July 2009
January 2010   (final data collection date for primary outcome measure)
Change in Mean Sitting Systolic Blood Pressure After 6 Weeks [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]
To compare the change from baseline in mean sitting systolic blood pressure (MSSBP) after 6 weeks of valsartan/amlodipine-based regimen with a losartan-based regimen in patients with Stage 2 systolic hypertension.
Change in mean sitting systolic blood pressure [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00931710 on ClinicalTrials.gov Archive Site
  • Change in Mean Sitting Diastolic Blood Pressure After 6 Weeks [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]
    To compare the change from baseline in mean sitting diastolic blood pressure (MSDBP) after 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.
  • Cumulative Percentage of Patients Achieving Blood Pressure Control [ Time Frame: 3 and 6 weeks ] [ Designated as safety issue: No ]
    To compare the percentage of patients achieving blood pressure control (defined as patients achieving MSSBP < 140 mmHg and MSDBP < 90 mmHg) after 3 and 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.
  • Cumulative Percentage of Treatment Responders [ Time Frame: 3 and 6 weeks ] [ Designated as safety issue: No ]
    To compare the percentage of treatment responders (defined as patients with MSSBP < 140 mmHg or demonstrating a decrease from baseline of ≥ 20 mmHg) after 3 and 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.
  • Change in Mean Sitting Systolic and Diastolic Blood Pressure After 12 Weeks [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
    To compare the change from baseline in MSSBP and MSDBP after 12 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.
  • Cumulative Percentage of Patients With Incidence of Peripheral Edema Before or at the Corresponding Visit [ Time Frame: 3, 6, 9 and 12 weeks ] [ Designated as safety issue: Yes ]
    To assess the incidence of peripheral edema occurring with valsartan/amlodipine-based regimen versus losartan-based regimen in patients with Stage 2 systolic hypertension.
  • Change in mean sitting diastolic blood pressure [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients achieving blood pressure control (defined as patients achieving mean sitting blood pressure less than 140 systolic and less than 90 diastolic [ Time Frame: 3 and 6 weeks ] [ Designated as safety issue: No ]
  • Proportion of treatment responders [ Time Frame: 3 and 6 weeks ] [ Designated as safety issue: No ]
  • Assessment of which treatment regimen achieves blood pressure control faster (blood pressure control [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Difference in change in mean sitting systolic and diastolic blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension
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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Stage 2 Systolic Hypertension
  • 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
  • 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.
    Intervention: Drug: valsartan, amlodipine, HCTZ
  • 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.
    Intervention: Drug: Losartan, HCTZ followed by valsartan, amlodipine, HCTZ
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
488
January 2010
January 2010   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00931710
CVEA489AUS01
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals 862-778-8300
Novartis
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP