Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension (EXALT)
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ClinicalTrials.gov Identifier: NCT00931710 |
Recruitment Status
:
Completed
First Posted
: July 2, 2009
Results First Posted
: February 4, 2011
Last Update Posted
: March 7, 2011
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Condition or disease | Intervention/treatment | Phase |
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Stage 2 Systolic Hypertension | Drug: valsartan, amlodipine, HCTZ Drug: Losartan, HCTZ followed by valsartan, amlodipine, HCTZ | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 488 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | July 2009 |
Actual Primary Completion Date : | January 2010 |
Actual Study Completion Date : | January 2010 |

Arm | Intervention/treatment |
---|---|
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.
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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
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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.
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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
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- Change in Mean Sitting Systolic Blood Pressure After 6 Weeks [ Time Frame: Baseline to Week 6 ]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 Diastolic Blood Pressure After 6 Weeks [ Time Frame: Baseline to Week 6 ]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 ]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 ]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 ]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 ]To assess the incidence of peripheral edema occurring with valsartan/amlodipine-based regimen versus losartan-based regimen in patients with Stage 2 systolic hypertension.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00931710
United States, New Jersey | |
sites in USA | |
East Hanover, New Jersey, United States |
Study Director: | Novartis Pharmaceuticals | 862-778-8300 |
Responsible Party: | External Affairs, Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00931710 History of Changes |
Other Study ID Numbers: |
CVEA489AUS01 |
First Posted: | July 2, 2009 Key Record Dates |
Results First Posted: | February 4, 2011 |
Last Update Posted: | March 7, 2011 |
Last Verified: | March 2011 |
Keywords provided by Novartis:
Hypertension combination therapy valsartan cardiovascular diseases |
Additional relevant MeSH terms:
Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Valsartan Losartan Hydrochlorothiazide Antihypertensive Agents Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Vasodilator Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Anti-Arrhythmia Agents Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors |