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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012196-10 | EudraCT Number |
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In consequence of termination of ALTITUDE. A number of studies were continued in consultation with the Altitude Data Monitoring Committee.
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The study is designed to primarily assess the effect of aliskiren on albuminuria in patients with non-diabetic nephropathy when treated with ramipril and volume intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram | Experimental | Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d. Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule HCTZ 25 mg o.d. Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d. Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d. |
|
| Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram | Experimental | Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d. Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule placebo to HCTZ 25 mg o.d. Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule HCTZ 25 mg o.d. Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren | Drug | Aliskiren 150 mg (Tablet) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Aliskiren on Albuminuria as Measured by Urinary Albumin Excretion Rate (UAER) | Two 24-hour collections of urine were to be made at each study visit. The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses. | 26 weeks |
| Effect of Aliskiren on Albuminuria as Measured by Creatinine Indexed Albumin | Two 24-hour collections of urine were to be made at each study visit. The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Sitting Systolic Blood Pressure (msSBP) | At study entry, blood pressure (BP) was measured in both arms. If there was a clinically relevant difference in readings between arms (≥ 10 mmHg in systolic BP and/or ≥ 5 mmHg in diastolic BP), the arm with higher BP reading was used. If there was no clinically significant difference between arms, the non-dominant arm was used through out study. Systolic blood pressure were assessed after the patient rested quietly in the sitting position for at least 3 minutes. For each sitting assessment, blood pressure was assessed at least 3 times. From these assessments, msSBP was calculated. All BP measurements were to be performed on the same arm. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria applied
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Groningen | Netherlands | ||||
| Novartis Investigative Site |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram | Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d. Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule HCTZ 25 mg o.d. Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d. Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (Day 1 to End of Week 6) |
|
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| Placebo to Aliskiren | Drug | Aliskiren 150 mg Matching Placebo (Tablet) |
|
| Hydrochlorothiazide (HCTZ) | Drug | HCTZ 25mg (Capsule) |
|
| Placebo to Hydrochlorothiazide (HCTZ) | Drug | HCTZ 25mg (Capsule) Matching Placebo |
|
| Ramipril | Drug | Ramipril 10mg (Tablet) |
|
| 26 weeks |
| Mean Sitting Diastolic Blood Pressure (msDBP) | At study entry, blood pressure (BP) was measured in both arms. If there was a clinically relevant difference in readings between arms (≥ 10 mmHg in systolic BP and/or ≥ 5 mmHg in diastolic BP), the arm with higher BP reading was used. If there was no clinically significant difference between arms, the non-dominant arm was used through out study. Diastolic blood pressure were assessed after the patient rested quietly in the sitting position for at least 3 minutes. For each sitting assessment, blood pressure was assessed at least 3 times. From these assessments, msDBP was calculated. All BP measurements were to be performed on the same arm. | 26 weeks |
| Mean Glomerular Filtration Rate (GFR) as Measurement of Renal Function | All patients had to visit the main center for renal function measurements. The measurements were performed using the constant infusion method with I-iothalamate (IOT) and I-hippuran. GFR was calculated as the urinary clearance of IOT. | 26 weeks |
| Mean Effective Renal Plasma Flow (ERPF) as One of Hemodynamic Assessments | 26 weeks |
| Percentage of Renal Filtration Fraction (RFF) as One of Hemodynamic Assessments | 26 weeks |
| Mean Extracellular Volume (ECV) as One of Hemodynamic Assessments | 26 weeks |
| Plasma Rennin Activity (PRA) | Blood biomarkers were obtained from blood samples in all patients at the time points such as baseline, week 6, week 12, week 18 and week 26. Plasma PRA is a direct measure of the formation of Ang I in the plasma. | Baseline to week 26 |
| Plasma Rennin Concentration (PRC) | Blood biomarkers were obtained from blood samples in all patients at the time points such as baseline, week 6, week 12, week 18 and week 26. PRC measures the concentration of immunoactive renin in the plasma. | Baseline to week 26 |
| Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril | 26 weeks |
| Leeuwarden |
| Netherlands |
| FG001 | Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram | Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d. Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule placebo to HCTZ 25 mg o.d. Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule HCTZ 25 mg o.d. Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Period 2 (Weeks 7 to 12) |
|
|
| Period 3 (Weeks 13 to 18) |
|
| Period 4 (Weeks 19 to 26) |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram | Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d. Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule HCTZ 25 mg o.d. Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d. Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d. |
| BG001 | Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram | Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d. Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule placebo to HCTZ 25 mg o.d. Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule HCTZ 25 mg o.d. Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effect of Aliskiren on Albuminuria as Measured by Urinary Albumin Excretion Rate (UAER) | Two 24-hour collections of urine were to be made at each study visit. The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses. | The study was terminated and consequentially was underpowered for adequate statistical analysis | Posted | 26 weeks |
|
| ||||||||||||||||||||||||||||
| Primary | Effect of Aliskiren on Albuminuria as Measured by Creatinine Indexed Albumin | Two 24-hour collections of urine were to be made at each study visit. The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses. | The study was terminated and consequentially was underpowered for adequate statistical analysis | Posted | 26 weeks |
| |||||||||||||||||||||||||||||
| Secondary | Mean Sitting Systolic Blood Pressure (msSBP) | At study entry, blood pressure (BP) was measured in both arms. If there was a clinically relevant difference in readings between arms (≥ 10 mmHg in systolic BP and/or ≥ 5 mmHg in diastolic BP), the arm with higher BP reading was used. If there was no clinically significant difference between arms, the non-dominant arm was used through out study. Systolic blood pressure were assessed after the patient rested quietly in the sitting position for at least 3 minutes. For each sitting assessment, blood pressure was assessed at least 3 times. From these assessments, msSBP was calculated. All BP measurements were to be performed on the same arm. | The study was terminated and consequentially was underpowered for adequate statistical analysis | Posted | 26 weeks |
| |||||||||||||||||||||||||||||
| Secondary | Mean Sitting Diastolic Blood Pressure (msDBP) | At study entry, blood pressure (BP) was measured in both arms. If there was a clinically relevant difference in readings between arms (≥ 10 mmHg in systolic BP and/or ≥ 5 mmHg in diastolic BP), the arm with higher BP reading was used. If there was no clinically significant difference between arms, the non-dominant arm was used through out study. Diastolic blood pressure were assessed after the patient rested quietly in the sitting position for at least 3 minutes. For each sitting assessment, blood pressure was assessed at least 3 times. From these assessments, msDBP was calculated. All BP measurements were to be performed on the same arm. | The study was terminated and consequentially was underpowered for adequate statistical analysis | Posted | 26 weeks |
| |||||||||||||||||||||||||||||
| Secondary | Mean Glomerular Filtration Rate (GFR) as Measurement of Renal Function | All patients had to visit the main center for renal function measurements. The measurements were performed using the constant infusion method with I-iothalamate (IOT) and I-hippuran. GFR was calculated as the urinary clearance of IOT. | The study was terminated and consequentially was underpowered for adequate statistical analysis | Posted | 26 weeks |
| |||||||||||||||||||||||||||||
| Secondary | Mean Effective Renal Plasma Flow (ERPF) as One of Hemodynamic Assessments | The study was terminated and consequentially was underpowered for adequate statistical analysis | Posted | 26 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Renal Filtration Fraction (RFF) as One of Hemodynamic Assessments | The study was terminated and consequentially was underpowered for adequate statistical analysis | Posted | 26 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Mean Extracellular Volume (ECV) as One of Hemodynamic Assessments | The study was terminated and consequentially was underpowered for adequate statistical analysis | Posted | 26 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Plasma Rennin Activity (PRA) | Blood biomarkers were obtained from blood samples in all patients at the time points such as baseline, week 6, week 12, week 18 and week 26. Plasma PRA is a direct measure of the formation of Ang I in the plasma. | The study was terminated and consequentially was underpowered for adequate statistical analysis | Posted | Baseline to week 26 |
| |||||||||||||||||||||||||||||
| Secondary | Plasma Rennin Concentration (PRC) | Blood biomarkers were obtained from blood samples in all patients at the time points such as baseline, week 6, week 12, week 18 and week 26. PRC measures the concentration of immunoactive renin in the plasma. | The study was terminated and consequentially was underpowered for adequate statistical analysis | Posted | Baseline to week 26 |
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril | The safety analysis set consisted of all patients who received at least one study drug and had no major protocol deviations that could have impacted safety data. | Posted | Number | Participants | 26 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ramipril +HCTZ | All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg | 0 | 8 | 7 | 8 | ||
| EG001 | Ramipril+Aliskiren + HCTZ | All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg * Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period | 0 | 7 | 5 | 7 | ||
| EG002 | Ramipril+Aliskiren | All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ *Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period | 0 | 7 | 3 | 7 | ||
| EG003 | Ramipril | All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ | 0 | 6 | 4 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Orthostatic intolerance | Nervous system disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Edema peripheral | General disorders | MedDRA | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
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| Renal function test abnormal | Investigations | MedDRA | Systematic Assessment |
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| Salt craving | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Snoring | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Tension headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA | Systematic Assessment |
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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 or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| C446481 | aliskiren |
| D006852 | Hydrochlorothiazide |
| D017257 | Ramipril |
| ID | Term |
|---|---|
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| OG003 | Ramipril | All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ |
|
| Ramipril+Aliskiren |
All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ *Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period |
| OG003 | Ramipril | All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ |
|
| Ramipril+Aliskiren |
All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ *Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period |
| OG003 | Ramipril | All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ |
|
| OG003 | Ramipril | All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ |
|
All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ |
|
All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ |
|
All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ |
|
| OG003 | Ramipril | All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ |
|
| OG003 | Ramipril | All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ |
|
| OG003 | Ramipril | All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ |
|
|