Trial Outcomes & Findings for Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension (NCT NCT00765947)

NCT ID: NCT00765947

Last Updated: 2020-08-06

Results Overview

For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure \[msSBP\] \< 140 mmHg and mean sitting Diastolic Blood Pressure \[msDBP\] \< 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure \[msSBP\] \< 130 mmHg and mean sitting Diastolic Blood Pressure \[msDBP\] \< 80 mmHg.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 256 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2020-08-06

Participant Flow

Participant milestones

Measure	Aliskiren-based Regimen Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
Overall Study STARTED	256
Overall Study COMPLETED	232
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension

Baseline characteristics by cohort

Measure	Aliskiren-based Regimen n=256 Participants Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
Age, Customized < 65 yrs	203 participants n=5 Participants
Age, Customized ≥ 65 yrs	53 participants n=5 Participants
Sex: Female, Male Female	113 Participants n=5 Participants
Sex: Female, Male Male	143 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Full analysis set

For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure [msSBP] < 130 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 80 mmHg.

Outcome measures

Measure	Aliskiren-based Regimen n=256 Participants Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen	86.12 Percentage of participants

SECONDARY outcome

Timeframe: 24 weeks

For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure [msSBP] < 130 mmHg and mean sitting Diastolic Blood Pressure [msDBP] < 80 mmHg.

Outcome measures

Measure	Aliskiren-based Regimen n=256 Participants Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
Percentage of Patients (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped-care, Aliskiren-based Regimen by Patient Subgroups of Mild and Moderate Hypertensive Patients, and Non-diabetic and Diabetic Patients. Mild Hypertensive	91.48 Percentage of Participants
Percentage of Patients (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped-care, Aliskiren-based Regimen by Patient Subgroups of Mild and Moderate Hypertensive Patients, and Non-diabetic and Diabetic Patients. Moderate Hypertensive	79.24 Percentage of Participants
Percentage of Patients (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped-care, Aliskiren-based Regimen by Patient Subgroups of Mild and Moderate Hypertensive Patients, and Non-diabetic and Diabetic Patients. Non-diabetic	92.74 Percentage of Participants
Percentage of Patients (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped-care, Aliskiren-based Regimen by Patient Subgroups of Mild and Moderate Hypertensive Patients, and Non-diabetic and Diabetic Patients. Diabetic	72.58 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set

Outcome measures

Measure	Aliskiren-based Regimen n=251 Participants Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
Changes From Baseline to Week 24 in Mean Sitting Systolic Blood Pressure [msSBP] and Mean Sitting Diastolic Blood Pressure [msDBP] msSBP	-25.33 mm Hg Standard Deviation 13.942
Changes From Baseline to Week 24 in Mean Sitting Systolic Blood Pressure [msSBP] and Mean Sitting Diastolic Blood Pressure [msDBP] msDBP	-12.40 mm Hg Standard Deviation 9.371

SECONDARY outcome

Timeframe: 24 weeks

Response for mean sitting Systolic Blood Pressure [msSBP] is defined as a reduction of ≥ 20 mmHg from baseline or mean sitting Systolic Blood Pressure [msSBP] < 140 mmHg (non diabetics) or < 130 mmHg (diabetics). Response for mean sitting Diastolic Blood Pressure [msDBP] is defined as a reduction of ≥10 mmHg from baseline or mean sitting Diastolic Blood Pressure [msDBP] < 90 mmHg (non diabetic) or < 80 mmHg (diabetics).

Outcome measures

Measure	Aliskiren-based Regimen n=256 Participants Patients initiated treatment with aliskiren 150 mg (up-titrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (up-titrated to 25 mg) and amlodipine 5 mg (up-titrated to 10 mg), as necessary to achieve the Blood Pressure goal.
Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP] msSBP	96.80 Percentage of Participants
Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP] msDBP	97.78 Percentage of Participants

Adverse Events

Aliskiren

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Aliskiren + HCTZ

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aliskiren + HCTZ + Amlodipine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aliskiren n=256 participants at risk Aliskiren treatment step	Aliskiren + HCTZ n=197 participants at risk Aliskiren and HCTZ treatment step	Aliskiren + HCTZ + Amlodipine n=119 participants at risk Aliskiren + HCTZ + Amlodipine treatment step
Cardiac disorders Myocardial infarction	0.39% 1/256	0.00% 0/197	0.00% 0/119
General disorders Non-cardiac chest pain	0.39% 1/256	0.00% 0/197	0.00% 0/119
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.39% 1/256	0.00% 0/197	0.00% 0/119
Vascular disorders Hypertension	0.39% 1/256	0.00% 0/197	0.00% 0/119

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER