Trial Outcomes & Findings for Study of the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension (NCT NCT00772577)

NCT ID: NCT00772577

Last Updated: 2011-03-11

Results Overview

To assess the change in mean sitting systolic blood pressure (MSSBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 386 participants
• Primary outcome timeframe: Baseline to week 8
• Results posted on: 2011-03-11

Participant Flow

Participant milestones

Measure	Aliskiren HCTZ Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks	Ramipril Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
Overall Study STARTED	193	193
Overall Study COMPLETED	170	170
Overall Study NOT COMPLETED	23	23

Reasons for withdrawal

Measure	Aliskiren HCTZ Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks	Ramipril Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
Overall Study Adverse Event	6	3
Overall Study Abnormal laboratory values	0	1
Overall Study Unsatisfactory therapeutic effect	0	8
Overall Study Patient withdrew consent	8	5
Overall Study Lost to Follow-up	4	3
Overall Study Administrative problems	2	1
Overall Study Protocol Deviation	3	2

Baseline Characteristics

Study of the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension

Baseline characteristics by cohort

Measure	Aliskiren HCTZ n=193 Participants Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks	Ramipril n=193 Participants Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks	Total n=386 Participants Total of all reporting groups
Age Continuous	55.4 years STANDARD_DEVIATION 11.15 • n=5 Participants	54.4 years STANDARD_DEVIATION 10.90 • n=7 Participants	54.9 years STANDARD_DEVIATION 11.02 • n=5 Participants
Sex: Female, Male Female	107 Participants n=5 Participants	99 Participants n=7 Participants	206 Participants n=5 Participants
Sex: Female, Male Male	86 Participants n=5 Participants	94 Participants n=7 Participants	180 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to week 8

Population: Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable). Last Observation Carried Forward (LOCF)

To assess the change in mean sitting systolic blood pressure (MSSBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).

Outcome measures

Measure	Aliskiren HCTZ n=190 Participants Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks	Ramipril n=190 Participants Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) Baseline	167.0 mm Hg Standard Deviation 7.05	168.2 mm Hg Standard Deviation 7.86
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) Week 8	138.9 mm Hg Standard Deviation 16.56	151.6 mm Hg Standard Deviation 17.44
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) Change from baseline to week 8	-28.1 mm Hg Standard Deviation 15.54	-16.6 mm Hg Standard Deviation 14.76

SECONDARY outcome

Timeframe: Baseline to week 8

Population: Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable). Last Observation Carried Forward (LOCF)

To evaluate the difference in mean sitting diastolic blood pressure (MSDBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).

Outcome measures

Measure	Aliskiren HCTZ n=190 Participants Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks	Ramipril n=190 Participants Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) Baseline	94.3 mm Hg Standard Deviation 8.41	96.3 mm Hg Standard Deviation 8.48
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) Week 8	84.2 mm Hg Standard Deviation 9.80	92.7 mm Hg Standard Deviation 11.07
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) Change from baseline to week 8	-10.1 mm Hg Standard Deviation 9.04	-3.6 mm Hg Standard Deviation 9.48

SECONDARY outcome

Timeframe: 8 weeks

Population: Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable).

The percentage of patients achieving the Blood Pressure control (defined as patients achieving a MSSBP < 140 mm Hg and MSDBP < 90 mm Hg) during 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg). Data presented are cumulative. Cumulative refers to achieving blood pressure control before or at the 8 week visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.

Outcome measures

Measure	Aliskiren HCTZ n=190 Participants Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks	Ramipril n=190 Participants Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
Percentage of Patients Achieving Blood Pressure Control During 8 Weeks	63.7 Percentage of patients	30.0 Percentage of patients

SECONDARY outcome

Timeframe: 8 weeks

Population: Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable).

To compare the percentage of responders (as defined by patients with MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg) during 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg). Data presented are cumulative. Cumulative refers to achieving the response before or at the 8 week visit. If response occurred more than once, only the first occurrence was counted.

Outcome measures

Measure	Aliskiren HCTZ n=190 Participants Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks	Ramipril n=190 Participants Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
Percentage of Responders (MSSBP < 140 mmHg or ≥ 20 mmHg Decrease From Baseline in MSSBP)	87.9 Percentage of patients	63.2 Percentage of patients

SECONDARY outcome

Timeframe: Baseline to week 8

Population: Intent-to-treat population (consisted of all patients who received at least one dose of study medication and had at least one valid post baseline assessment of primary efficacy variable). Last Observation Carried Forward (LOCF)

To compare the change in mean sitting pulse pressure (MSPP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).

Outcome measures

Measure	Aliskiren HCTZ n=190 Participants Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks	Ramipril n=190 Participants Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
Change From Baseline in Mean Sitting Pulse Pressure (MSPP) Baseline	72.7 mm Hg Standard Deviation 10.44	71.9 mm Hg Standard Deviation 9.85
Change From Baseline in Mean Sitting Pulse Pressure (MSPP) Week 8	54.7 mm Hg Standard Deviation 13.87	58.9 mm Hg Standard Deviation 13.98
Change From Baseline in Mean Sitting Pulse Pressure (MSPP) Change from baseline to week 8	-18.0 mm Hg Standard Deviation 12.14	-13.0 mm Hg Standard Deviation 12.12

Adverse Events

Aliskiren HCTZ

Serious events: 4 serious events

Other events: 14 other events

Deaths: 0 deaths

Ramipril

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aliskiren HCTZ n=193 participants at risk Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks	Ramipril n=193 participants at risk Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
Gastrointestinal disorders Pancreatitis	0.52% 1/193 • 8 weeks	0.00% 0/193 • 8 weeks
General disorders Chest pain	0.52% 1/193 • 8 weeks	0.00% 0/193 • 8 weeks
General disorders Non-cardiac chest pain	0.52% 1/193 • 8 weeks	0.00% 0/193 • 8 weeks
Metabolism and nutrition disorders Dehydration	0.52% 1/193 • 8 weeks	0.00% 0/193 • 8 weeks
Nervous system disorders Convulsion	0.00% 0/193 • 8 weeks	0.52% 1/193 • 8 weeks
Renal and urinary disorders Pollakiuria	0.52% 1/193 • 8 weeks	0.00% 0/193 • 8 weeks
Vascular disorders Deep vein thrombosis	0.52% 1/193 • 8 weeks	0.00% 0/193 • 8 weeks
Vascular disorders Hypertension	0.00% 0/193 • 8 weeks	0.52% 1/193 • 8 weeks

Other adverse events

Measure	Aliskiren HCTZ n=193 participants at risk Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks	Ramipril n=193 participants at risk Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks
Nervous system disorders Headache	7.3% 14/193 • 8 weeks	8.8% 17/193 • 8 weeks

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