Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension

Phase 2

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: Valsartan + amlodipine 40/2.5 mg; Drug: Valsartan + amlodipine 40/5 mg; Drug: Valsartan + amlodipine 80/2.5 mg; Drug: Valsartan + amlodipine 80/5 mg; Drug: Valsartan 40 mg; Drug: Valsartan 80 mg; Drug: Amlodipine 2.5 mg; Drug: Placebo; Drug: Amlodipine 5 mg

• Registration Number: NCT00425373
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of fixed combination of valsartan (40 mg and 80 mg) and amlodipine (2.5 mg and 5 mg), valsartan and amlodipine alone, and placebo in reducing blood pressure. The study will investigate the dose response relationship for the combinations, monotherapies, and placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-01-22
• Study First Submitted QC: 2007-01-22
• Study First Posted: 2007-01-23
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Results First Submitted: 2011-01-12
• Results First Submitted QC: 2011-01-12
• Results First Posted: 2011-02-04
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-20
• Last Update Posted: 2011-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1474

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Valsartan + amlodipine 40/2.5 mg	Valsartan + amlodipine 40/2.5 mg	-
Valsartan + amlodipine 40/5 mg	Valsartan + amlodipine 40/5 mg	-
Valsartan + amlodipine 80/2.5 mg	Valsartan + amlodipine 80/2.5 mg	-
Valsartan + amlodipine 80/5 mg	Valsartan + amlodipine 80/5 mg	-
Valsartan 40 mg	Valsartan 40 mg	-
Valsartan 80 mg	Valsartan 80 mg	-
Amlodipine 2.5 mg	Amlodipine 2.5 mg	-
Placebo	Placebo	-
Amlodipine 5 mg	Amlodipine 5 mg	-

Primary Outcome Measures

Name	Time	Method
Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8)	Baseline to end of study (Week 8)	At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.

Secondary Outcome Measures

Name	Time	Method
Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Study (Week 8)	Baseline to end of study (Week 8)	At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Percentage of Patients Achieving MSDBP < 90 mmHg or a => 10 mm Hg Decrease Compared to Baseline at the End of the Study (Week 8)	Baseline to end of study (Week 8)	At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Percentage of Patients Achieving MSDBP < 90mmHg at the End of the Study (Week 8)	Baseline to end of study (Week 8)	At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Percentage of Patients Achieving MSDBP < 90 mm Hg and MSSBP < 140 mm Hg at the End of the Study (Week 8)	Baseline to end of study (Week 8)	At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇯🇵 Tokyo, Japan