Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension

Hypertension Clinical Trial

Official title:

An 8 Week, Double-blind, Randomized, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate to Severe Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765674
• Other study ID #: CSAH100A2302
• Status: Completed
• Phase: Phase 3
• First received: October 2, 2008
• Last updated: April 15, 2011
• Start date: September 2008
• Est. completion date: August 2009

Study information

• Verified date: April 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesCanada: Health CanadaItaly: National Institute of HealthSweden: Medical Products AgencyRomania: National Medicines AgencyAustralia: Department of Health and Ageing Therapeutic Goods AdministrationUnited States: Food and Drug AdministrationDenmark: Danish Medicines AgencyIsrael: Ministry of HealthLithuania: State Medicine Control Agency - Ministry of HealthZanzibar: Ministry of Health and Social WelfareLatvia: State Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

This study evaluated the efficacy (blood pressure lowering effect) and safety of aliskiren/amlodipine/hydrochlorothiazide in patients with moderate to severe hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1191
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female

• 18 years of age or older

• msDBP and msSBP requirements:

• 3A:

• Diagnosis of moderate to severe hypertension (msSBP = 160 mmHg and < 200 mmHg, and/or msDBP = 100 mmHg and < 120 mmHg) at Visits 4, 5 or 6 (Qualifying BP visit)

• In addition, at the visit immediately prior to the above qualifying visit, patients were also to have msSBP = 145 mmHg and < 200 mmHg and msDBP = 95 mmHg and < 120 mmHg) at Visits 3, 5 or 5.

• Patients had to meet the above two sets of requirements at subsequent adjacent visits, i.e. either Visits 3 and 4, Visits 4 and 5, or Visits 5 and 6.

• OR

• 3B:

• msSBP = 180 mmHg and < 200 mmHg with msDBP = 95 mmHg and < 120 mmHg, or msDBP = 110 mmHg and < 120 mmHg with msSBP = 150 mmHg and < 200 mmHg after at least one week of treatment with placebo (Visit 3 and on).

Exclusion Criteria:

• Continued use of anti-hypertensive medicines or use of 4 or more hypertensive medicines at study start

• Patients with an msSBP = 200 mmHg or msDBP = 120 mmHg at any time during the placebo run-in period were to be discontinued from the study.

• Extremely elevated (defined) blood pressure at any point during the study

• Pregnant or lactating women

• Pre-menopausal women not taking accepted form of birth control

• History or evidence of secondary form of hypertension

• History of cardiovascular conditions

Other protocol-defined inclusion/exclusion criteria applied to the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Aliskiren
150 and 300 mg tablets
• Amlodipine
5 and 10 mg capsules
• Hydrochlorothiazide (HCTZ)
12.5 and 25 mg capsules
• Placebo
tablet
• Placebo
capsules

Locations

Country	Name	City	State
Australia	Investigative Site	Sydney
Canada	Investigative Site	Ottawa
Denmark	Investigative Site	Copenhagen
Germany	Investigative Site	Berlin
Israel	Investigative Site	Jerusalem
Italy	Investigative Site	Rome
Latvia	Investigative Site	Riga
Lithuania	Investigative Site	Vilnius
Romania	Investigative Site	Bucharest
Sweden	Investigative Site	Stockholm
Turkey	Investigative Site	Ankara
United States	Investigative Site	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Denmark,  Germany,  Israel,  Italy,  Latvia,  Lithuania,  Romania,  Sweden,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)	Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.	Baseline to end of study (Week 8)	No
Secondary	Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)	Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was < 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated. A negative change indicates lowered BP.	Baseline to end of study (Week 8)	No
Secondary	Percentage of Patients Achieving Blood Pressure Control at the End of the Study (Week 8)	Blood pressure control was defined as a msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate size cuff. Means of the 3 measurements were calculated.	End of study (Week 8)	No
Secondary	Change in Mean 24-hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study (Week 8)	Twenty-four hour ambulatory blood pressure monitoring (ABPM) was performed in a subset of patients twice during the study, once at baseline and again at Week 8. The ABPM device was placed on the non-dominant arm between 7:00 and 10:00 am and verification readings obtained. If they were successful, the investigator initiated the 24 hour reading and instructed the patient regarding ABPM procedures. On the next day, the ABPM device was removed if it had been worn for a minimum of 24 hours. The ABPM data were downloaded and evaluated on site.	Baseline to end of study (Week 8)	No