A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Participants With Essential Hypertension

Essential Hypertension Clinical Trial

Official title:

A 28 to 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren / Amlodipine / Hydrochlorothiazide in Patients With Essential Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00667719
• Other study ID #: CSAH100A2301
• Secondary ID: 2008-001242-10
• Status: Completed
• Phase: Phase 3
• Start date: June 5, 2008
• Est. completion date: October 5, 2009

Study information

• Verified date: May 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study tested the safety of the combination of aliskiren/amlodipine/hydrochlorothiazide in participants with essential hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 564
• Est. completion date: October 5, 2009
• Est. primary completion date: October 5, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Outpatients 18 years of age or older

• Male or female participants are eligible.

• Mean sitting diastolic blood pressure (msDBP) and mean sitting systolic blood pressure (msSBP) Requirements:

• For newly diagnosed/untreated participants, msDBP = 100 and < 120 millimeters of mercury (mmHg), and/or msSBP = 160 and < 200 mmHg at Visit 1 and Visit 2.

• For previously treated participants, msDBP = 100 and < 120 mmHg, and/or msSBP = 160 and < 200 mmHg at Visit 2, Visit 3, or Visit 4.

• For participants requiring tapering off their previous antihypertensive medication, they must meet the above criteria and completely discontinue all antihypertensive treatment prior to entering the treatment phase of the study.

• Participants who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).

Exclusion Criteria:

• Inability to discontinue all prior antihypertensive medications safely for a period of 1 week to 4 weeks as required by the protocol.

• Participants on three antihypertensive drugs with msDBP = 110 mmHg and/or msSBP = 180 mmHg at Visit 1.

• Participants on four or more antihypertensive drugs at Visit 1.

• Participants with an msSBP = 200 and msDBP = 120 mmHg anytime during the washout period of the study Visit 1-4 must be discontinued from the study.

• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (>= 5 milli-international units per milliliter mIU/mL).

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Aliskiren
300 mg tablet
• Amlodipine
5 mg tablet
• Hydrochlorothiazide
12.5 mg and 25 mg capsule

Locations

Country	Name	City	State
Belgium	Investigative Site	Belgium
Egypt	Investigative Site	Egypt
Germany	Investigative Site	Germany
Poland	Investigative Site	Poland
Slovakia	Investigative Site	Slovakia
Spain	Investigative Site	Spain
Turkey	Investigative Site	Turkey
United States	Investigative Site	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Belgium,  Egypt,  Germany,  Poland,  Slovakia,  Spain,  Turkey, 

References & Publications (1)

Murray AV, Koenig W, Garcia-Puig J, Patel S, Uddin A, Zhang J. Safety and efficacy of aliskiren/amlodipine/hydrochlorothiazide triple combination in patients with moderate to severe hypertension: a 54-week, open-label study. J Clin Hypertens (Greenwich). — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Death	An AE was defined as the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug, even if the event is not considered to be related to study drug. An SAE was defined as an event which was fatal or life-threatening, resulted in persistent or significant disability/incapacity, constituted a congenital anomaly/birth defect, required inpatient hospitalization or prolongation of existing hospitalization, was medically significant, i.e. defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above.	54 weeks
Secondary	Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)	The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the participant in a sitting position for five minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28.	Baseline, Weeks 28 and 54 endpoint
Secondary	Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)	The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the participant in a sitting position for five minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28.	Baseline, Weeks 28 and 54 endpoints
Secondary	Percentage of Participants Achieving the Blood Pressure Control Target of <140/90 mmHg	Blood pressure control was defined as having a mean sitting diastolic blood pressure <90 mmHg and a mean sitting systolic blood pressure <140 mmHg. Percentage of participants achieving the blood pressure control of < 140/90 mmHg were reported. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28 and Week 54 Endpoint was the last non-missing measurement value after Week 28.	Weeks 28 and 54 endpoints
Secondary	Percentage of Participants Who Achieved a Blood Pressure Response in Mean Sitting Diastolic Blood Pressure	Diastolic Blood pressure response was defined as a mean sitting diastolic blood pressure <90 mmHg or a >=10 mmHg reduction from baseline value. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28.	Weeks 28 and 54 endpoints
Secondary	Percentage of Participants Who Achieved a Blood Pressure Response in Mean Sitting Systolic Blood Pressure	Systolic blood pressure response was defined as a mean sitting systolic blood pressure <140 mmHg or a >=20 mmHg reduction from baseline value. Week 28 Endpoint was the last non-missing post-baseline measurement value on or before Week 28, and Week 54 Endpoint was the last non-missing measurement value after Week 28.	Weeks 28 and 54 endpoints