Trial Outcomes & Findings for Aliskiren Plus HCTZ Compared to Aliskiren in Metabolic Syndrome Patients With Stage 2 Systolic Hypertension (NCT NCT00797316)

NCT ID: NCT00797316

Last Updated: 2011-03-11

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 532 participants
• Primary outcome timeframe: Baseline and Week 8
• Results posted on: 2011-03-11

Participant Flow

Participant milestones

Measure	Aliskiren/HCTZ Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.	Aliskiren Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
Overall Study STARTED	267	265
Overall Study COMPLETED	244	233
Overall Study NOT COMPLETED	23	32

Reasons for withdrawal

Measure	Aliskiren/HCTZ Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.	Aliskiren Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
Overall Study Administrative problems	1	0
Overall Study Adverse Event	5	3
Overall Study Lost to Follow-up	4	8
Overall Study Protocol Deviation	1	2
Overall Study Patient withdrew consent	12	6
Overall Study Unsatisfactory therapeutic effect	0	13

Baseline Characteristics

Aliskiren Plus HCTZ Compared to Aliskiren in Metabolic Syndrome Patients With Stage 2 Systolic Hypertension

Baseline characteristics by cohort

Measure	Aliskiren/HCTZ n=267 Participants Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.	Aliskiren n=265 Participants Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.	Total n=532 Participants Total of all reporting groups
Age Continuous	54.4 years STANDARD_DEVIATION 11.09 • n=5 Participants	53.5 years STANDARD_DEVIATION 10.87 • n=7 Participants	53.9 years STANDARD_DEVIATION 10.98 • n=5 Participants
Age, Customized < 65	217 participants n=5 Participants	233 participants n=7 Participants	450 participants n=5 Participants
Age, Customized >= 65	50 participants n=5 Participants	32 participants n=7 Participants	82 participants n=5 Participants
Sex: Female, Male Female	128 Participants n=5 Participants	129 Participants n=7 Participants	257 Participants n=5 Participants
Sex: Female, Male Male	139 Participants n=5 Participants	136 Participants n=7 Participants	275 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 8

Population: Full analysis set

Outcome measures

Measure	Aliskiren/HCTZ n=264 Participants Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.	Aliskiren n=261 Participants Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
Change From Baseline to Week 8 in Mean Sitting Systolic Blood Pressure (msSBP)	-30.38 mm Hg Standard Error 1.01	-20.15 mm Hg Standard Error 1.01

SECONDARY outcome

Timeframe: 8 weeks

Population: Full analysis set

Outcome measures

Measure	Aliskiren/HCTZ n=264 Participants Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.	Aliskiren n=261 Participants Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
Change From Baseline to Week 8 in Mean Sitting Diastolic Blood Pressure (msDBP)	-11.26 mm Hg Standard Error 0.59	-6.90 mm Hg Standard Error 0.60

SECONDARY outcome

Timeframe: 8 weeks

Population: full analysis set

Response is defined as a patient with msSBP < 140 mmHg or a decrease from baseline ≥ 20 mmHg in msSBP during eight weeks of treatment.

Outcome measures

Measure	Aliskiren/HCTZ n=264 Participants Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.	Aliskiren n=261 Participants Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
Percentage of Participants With Blood Pressure Response at Week 8	78.4 Percentage of Participants	55.2 Percentage of Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Full analysis set

Blood pressure control is defined as a patient who achieves a target Blood Pressure of mean sitting Systolic Blood Pressure / mean sitting Diastolic Blood pressure < 140/90 mmHg.

Outcome measures

Measure	Aliskiren/HCTZ n=264 Participants Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.	Aliskiren n=261 Participants Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
Percentage of Patients Achieving Blood Pressure Control at Week 8	58.7 Percentage of Participants	34.5 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: Full analysis set

Outcome measures

Measure	Aliskiren/HCTZ n=264 Participants Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.	Aliskiren n=261 Participants Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
Change From Baseline to Week 8 in Pulse Pressure	-18.96 mm Hg Standard Error 0.74	-13.33 mm Hg Standard Error 0.74

Adverse Events

Aliskiren/HCTZ

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

Aliskiren

Serious events: 4 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aliskiren/HCTZ n=267 participants at risk Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.	Aliskiren n=265 participants at risk Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
Cardiac disorders Acute myocardial infarction	0.00% 0/267	0.38% 1/265
Infections and infestations Cellulitis	0.37% 1/267	0.00% 0/265
Infections and infestations Gastroenteritis viral	0.00% 0/267	0.38% 1/265
Infections and infestations Pneumonia	0.37% 1/267	0.00% 0/265
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/267	0.38% 1/265
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.37% 1/267	0.00% 0/265
Psychiatric disorders Alcohol abuse	0.00% 0/267	0.38% 1/265

Other adverse events

Measure	Aliskiren/HCTZ n=267 participants at risk Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.	Aliskiren n=265 participants at risk Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
Nervous system disorders Headache	4.9% 13/267	6.8% 18/265

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