Phase 4
N=1,143
Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00927394 ↗Enrolled (actual)
1,143
Serious AEs
1.6%
Results posted
Oct 2012
Primary outcome: Primary: Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) at Week 8 — -15.3; -11.5 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aliskiren (Drug); Valsartan (Drug); Placebo for Aliskiren (Drug); Placebo for Valsartan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) at Week 8 |
-15.3; -11.5 | — |
| SECONDARY Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) |
-21.7; -18.2 | — |
| SECONDARY Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) at Week 8 |
-9.2; -6.7 | — |
| SECONDARY Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (MAPP) at Week 8 |
-6.1; -4.7 | — |
| SECONDARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) |
-11.0; -8.3 | — |
| SECONDARY Change From Baseline in Mean Sitting Pulse Pressure (MSPP) at Week 8 |
-10.8; -9.9 | — |
| SECONDARY Percentage of Patients Achieving Blood Pressure Control |
39.9; 32.7 | — |
| SECONDARY Percentage of Responders |
61.9; 53.8 | — |
| SECONDARY Change From Baseline in Plasma Renin Activity (PRA) at Week 8 |
1.056; 0.879 | — |
| SECONDARY Change From Baseline in Plasma Renin Concentration (PRC) at Week 8 |
68.592; 124.721 | — |
| SECONDARY Change From Baseline in Plasma Aldosterone at Week 8 |
-21.957; -22.562 | — |
| SECONDARY Number of Patients With Adverse Events, Serious Adverse Events and Death |
202; 182; 9; 9; 1; 1 | — |
Summary
The purpose of the study was to evaluate the blood pressure (BP)-lowering efficacy of the combination of aliskiren and valsartan, as initial therapy, compared to valsartan monotherapy in Type II Diabetic patients with Stage II hypertension.
Eligibility Criteria
Inclusion Criteria
- Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
- Men or women 18 years and older.
- Patients with Type 2 diabetes mellitus with an HbA1c ≤ 9 % at visit 1 and on a stable anti-diabetic regimen not including insulin or stable diet and exercise for at least 4 weeks prior to visit 1.
Cohort 1:
- Patients with Stage 2 systolic hypertension, defined as having a MSSBP ≥160 mmHg and <200 mmHg at Visit 5 (randomization).
- Patients who have been newly diagnosed with hypertension or who have not received antihypertensive medication for at least 4 weeks (28 days) prior to Visit 1 must have MSSBP ≥ 160 mmHg and < 200 mmHg at Visit 1, otherwise, they will be considered screen failures.
- Patients receiving antihypertensive medication must have a MSSBP of ≥150 mmHg and <200 mmHg at Study Visit 1, otherwise they will be considered screen failures.
Cohort 2:
- Patients must also have had a mean 8-hour daytime ambulatory systolic blood pressure (ASBP) ≥140 mmHg AND mean 8-hour daytime ambulatory diastolic blood pressure (ADBP) ≥90 mmHg at Visit 5 (randomization).
- Hypertensive patients with MSSBP ≥150 mmHg and but <200 mmHg AND MSDBP ≥95 but <120 mmHg at Visit 5 (randomization).
- Patients who had been newly diagnosed with hypertension or who had not received antihypertensive medication for at least 4 weeks (28 days) prior to Visit 1 must have had MSSBP ≥150 mmHg but <200 mmHg and MSDBP ≥95 but <120 mmHg at Visit 1, otherwise, they were considered screen failures.
Exclusion Criteria
- Office blood pressure measured by cuff (MSSBP ≥200 mmHg or MSDBP ≥120 mmHg).
- History or evidence of secondary hypertension of any etiology.
- Refractory hypertension, defined as having uncontrolled BP (≥140/90 mmHg) while receiving 3 antihypertensive medications at the maximum approved dose of each drug, one of which must be a diuretic.
- Patients treated with more than 3 antihypertensive medications (each component of a combination drug counts individually).
- Type 2 diabetes mellitus currently requiring insulin treatment.
- modification of diet in renal disease (MDRD) estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2
- Serum sodium less than lower limit of normal, serum potassium < 3.5 mEq/L or ≥ 5.3 mEq/L at Visit 1.
- Known Keith-Wagener grade III or IV hypertensive retinopathy.
Cohort 1:
- Patients with known diabetic retinopathy (eg, having a history of laser therapy for diabetic retinopathy) or diabetic neuropathy (eg, receiving medication for diabetic neuropathy).
Cohort 2:
- Patients with known diabetic retinopathy or diabetic neuropathy and/or having a history of treatment for either.
Other protocol-defined inclusion/exclusion criteria applied.
Data sourced from ClinicalTrials.gov (NCT00927394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.