Essential Hypertension Clinical Trial
Official title:
An 8-week Double-blind, Multicenter, Randomized, 6-arm, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in Patients With Essential Hypertension
Verified date | May 2012 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Pharmaceuticals and Medical Devices Agency |
Study type | Interventional |
The purpose of the study was to evaluate the efficacy (blood pressure lowering effect) and safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in patients with essential hypertension (mean sitting diastolic blood pressure [msDBP] ≥ 95 mmHg and < 110 mmHg and mean sitting systolic blood pressure [msSBP] ≥ 140 mmHg ). This study was conducted to support registration of the fixed-dose combination of aliskiren and amlodipine for the treatment of hypertension in Japan.
Status | Completed |
Enrollment | 1342 |
Est. completion date | May 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Patients with essential hypertension (msDBP = 95 mmHg and < 110 mmHg and msSBP =140 mmHg ) - Outpatients Exclusion Criteria: - Severe hypertension (msDBP =110 mmHg and/or msSBP = 180 mmHg) - History of allergy or hypersensitivity to renin inhibitors, calcium channel blockers - History or evidence of a secondary hypertension Other protocol-defined inclusion/exclusion criteria applied |
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Investigative Site | Aichi | |
Japan | Investigative Site | Ehime | |
Japan | Investigative Site | Fukuoka | |
Japan | Investigative Site | Hokkaido | |
Japan | Investigative Site | Hyogo | |
Japan | Investigative Site | Kanagawa | |
Japan | Investigative Site | Kyoto | |
Japan | Investigative Site | Okayama | |
Japan | Investigative Site | Osaka | |
Japan | Investigative Site | Saitama | |
Japan | Investigative Site | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Novartis |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8) | Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate. | Baseline, Week 8 | No |
Secondary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) to End of Study (Week 8) | Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate. | Baseline, Week 8 | No |
Secondary | Percentage of Participants Achieving Blood Pressure Control at Endpoint | Blood pressure control is defined as having as a msDBP < 90 mmHg and a msSBP < 140 mmHg. | 8 weeks | No |
Secondary | Percentage of Participants Achieving a Successful Response Rate | The response rate was defined as percentage of participants who achieved msDBP < 90 mmHg or its reduction = 10 mmHg from baseline to endpoint. | 8 weeks | No |
Secondary | Number of Participants With Adverse Events, Serious Adverse Events and Death | Number of patients with adverse events regardless of study drug relationship during the double-blind treatment period were reported. Serious adverse events of double blind period were reported. | 8 weeks | Yes |
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