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DIabetic Retinopathy Candesartan Trials. (DIRECT)

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ClinicalTrials.gov Identifier: NCT00252720
Recruitment Status : Completed
First Posted : November 15, 2005
Results First Posted : June 3, 2014
Last Update Posted : June 3, 2014
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Intervention Drug: candesartan
Enrollment 1850
Recruitment Details First subject enrolled in the DIRECT programme 8 June 2001 and last subject completed the DIRECT programme 16 April 2008 mainly in hospital based clinics. The study investigators enrolled 4514 patients with type 1 diabetes to either Study 45 or 46, of whom 1905 proceeded to randomization into Study 46 (1421 into Study 45).
Pre-assignment Details The most common reason for not being randomized was that all eligibility criteria were not fulfilled, followed by withdrawn informed consent.
Arm/Group Title Candesartan Placebo
Hide Arm/Group Description Candesartan cilexetil 32 mg once daily Placebo Comparator
Period Title: Overall Study
Started 951 954
Completed 819 789
Not Completed 132 165
Reason Not Completed
Withdrawal by Subject             95             97
Death             7             8
Moving             23             42
Mainly patients lost to follow-up             7             18
Arm/Group Title Candesartan Placebo Total
Hide Arm/Group Description Candesartan cilexetil 32 mg once daily Placebo Comparator Total of all reporting groups
Overall Number of Baseline Participants 951 954 1905
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 951 participants 954 participants 1905 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
951
 100.0%
954
 100.0%
1905
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 951 participants 954 participants 1905 participants
31.5  (8.5) 31.9  (8.5) 31.7  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 951 participants 954 participants 1905 participants
Female
413
  43.4%
401
  42.0%
814
  42.7%
Male
538
  56.6%
553
  58.0%
1091
  57.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 951 participants 954 participants 1905 participants
Russian Federation 186 162 348
Europe 595 619 1214
Canada 69 71 140
South Africa 101 102 203
1.Primary Outcome
Title Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale
Hide Description Retinopathy progression was defined as the first occurrence of at least a 3-step increase in the ETDRS severity scale. 3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments.
Time Frame From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population was the Intention to Treat population which includes all randomized patients with any post-randomization data.
Arm/Group Title Candesartan Placebo
Hide Arm/Group Description:
Candesartan cilexetil 32 mg once daily
Placebo Comparator
Overall Number of Participants Analyzed 951 954
Measure Type: Number
Unit of Measure: Participants
127 124
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Candesartan, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8487
Comments [Not Specified]
Method Log Rank
Comments Generalized
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.024
Confidence Interval (2-Sided) 95%
0.800 to 1.312
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With a Regression of Diabetic Retinopathy.
Hide Description Regression of diabetic retinopathy was defined as at least a 3 step improvement or a persistent 2-step improvement (confirmed in 2 consecutive photography sets) in the Early Treatment of Diabetic Retinopathy Study (ETDRS) severity scale. 3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11).
Time Frame From baseline to the end of the study, i.e., 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.
Arm/Group Title Candesartan Placebo
Hide Arm/Group Description:
Candesartan cilexetil 32 mg once daily
Placebo Comparator
Overall Number of Participants Analyzed 951 954
Measure Type: Number
Unit of Measure: Participants
140 139
3.Secondary Outcome
Title Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR).
Hide Description Clinically Significant Macular Edema (CSME) and Proliferative Diabetic Retinopathy (PDR) are diagnosed via retinal photographs.
Time Frame From baseline to end of study, i.e. 5 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population was the Intention To Treat population whick includes all randomized patients with any post-randomization data.
Arm/Group Title Candesartan Placebo
Hide Arm/Group Description:
Candesartan cilexetil 32 mg once daily
Placebo Comparator
Overall Number of Participants Analyzed 951 954
Measure Type: Number
Unit of Measure: Participants
110 107
4.Secondary Outcome
Title Rate of Change in Urinary Albumin Excretion Rate (UAER).
Hide Description An estimate of the slope from fitting a linear regression of log (UAER) over time (post-randimisation, yearly assessments) for each patient
Time Frame From baseline to end of study, i.e. 5 years.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population was the Intention To Treat population which includes all randimized patients with any post-randomization data.
Arm/Group Title Candesartan Placebo
Hide Arm/Group Description:
Candesartan cilexetil 32 mg once daily
Placebo Comparator
Overall Number of Participants Analyzed 951 954
Least Squares Mean (95% Confidence Interval)
Unit of Measure: log (µg/min)/year
0.569
(0.489 to 0.648)
0.642
(0.563 to 0.722)
Time Frame During treatment. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment.
Adverse Event Reporting Description Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.
 
Arm/Group Title Candesartan Placebo
Hide Arm/Group Description Candesartan cilexetil 32 mg once daily Placebo Comparator
All-Cause Mortality
Candesartan Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Candesartan Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   173/951 (18.19%)   161/951 (16.93%) 
Blood and lymphatic system disorders     
Idiopathic Thrombocytopenic Purpura  1  1/951 (0.11%)  1/951 (0.11%) 
Iron Deficiency Anaemia  1  1/951 (0.11%)  0/951 (0.00%) 
Thrombocytopenic Purpura  1  1/951 (0.11%)  0/951 (0.00%) 
Cardiac disorders     
Myocardial Infarction  1  1/951 (0.11%)  2/951 (0.21%) 
Acute Myocardial Infarction  1  0/951 (0.00%)  1/951 (0.11%) 
Angina Pectoris  1  0/951 (0.00%)  1/951 (0.11%) 
Cardiovascular Disorder  1  0/951 (0.00%)  1/951 (0.11%) 
Congenital, familial and genetic disorders     
Heart Disease Congenital  1  0/951 (0.00%)  1/951 (0.11%) 
Hepato-Lenticular Degeneration  1  0/951 (0.00%)  1/951 (0.11%) 
Ear and labyrinth disorders     
Ear Congestion  1  0/951 (0.00%)  1/951 (0.11%) 
Sudden Hearing Loss  1  0/951 (0.00%)  1/951 (0.11%) 
Vestibular Neuronitis  1  1/951 (0.11%)  0/951 (0.00%) 
Endocrine disorders     
Addison's Disease  1  1/951 (0.11%)  0/951 (0.00%) 
Eye disorders     
Cataract  1  0/951 (0.00%)  1/951 (0.11%) 
Conjunctivitis  1  1/951 (0.11%)  0/951 (0.00%) 
Diabetic Blindness  1  0/951 (0.00%)  1/951 (0.11%) 
Eye Haemorrhage  1  0/951 (0.00%)  1/951 (0.11%) 
Gastrointestinal disorders     
Gastritis  1  5/951 (0.53%)  2/951 (0.21%) 
Abdominal Pain  1  2/951 (0.21%)  1/951 (0.11%) 
Inguinal Hernia  1  0/951 (0.00%)  2/951 (0.21%) 
Abdominal Adhesions  1  0/951 (0.00%)  1/951 (0.11%) 
Abdominal Pain Lower  1  0/951 (0.00%)  1/951 (0.11%) 
Anal Fissure  1  1/951 (0.11%)  0/951 (0.00%) 
Change Of Bowel Habit  1  0/951 (0.00%)  1/951 (0.11%) 
Coeliac Disease  1  1/951 (0.11%)  1/951 (0.11%) 
Diarrhoea  1  0/951 (0.00%)  1/951 (0.11%) 
Duodenal Ulcer Perforation  1  1/951 (0.11%)  0/951 (0.00%) 
Dyspepsia  1  1/951 (0.11%)  1/951 (0.11%) 
Food Poisoning  1  0/951 (0.00%)  1/951 (0.11%) 
Gastric Ulcer  1  1/951 (0.11%)  0/951 (0.00%) 
Gastrointestinal Haemorrhage  1  0/951 (0.00%)  1/951 (0.11%) 
Gingival Disorder  1  0/951 (0.00%)  1/951 (0.11%) 
Hiatus Hernia  1  0/951 (0.00%)  1/951 (0.11%) 
Irritable Bowel Syndrome  1  1/951 (0.11%)  0/951 (0.00%) 
Pancreatitis Acute  1  0/951 (0.00%)  1/951 (0.11%) 
Rectal Polyp  1  0/951 (0.00%)  1/951 (0.11%) 
Vomiting  1  1/951 (0.11%)  0/951 (0.00%) 
General disorders     
Chest Pain  1  5/951 (0.53%)  0/951 (0.00%) 
Death  1  0/951 (0.00%)  1/951 (0.11%) 
Foreign Body Reaction  1  0/951 (0.00%)  1/951 (0.11%) 
Macrosomia  1  0/951 (0.00%)  1/951 (0.11%) 
Oedema  1  1/951 (0.11%)  0/951 (0.00%) 
Oedema Peripheral  1  1/951 (0.11%)  0/951 (0.00%) 
Organ Failure  1  0/951 (0.00%)  1/951 (0.11%) 
Pyrexia  1  0/951 (0.00%)  1/951 (0.11%) 
Hepatobiliary disorders     
Cholelithiasis  1  1/951 (0.11%)  1/951 (0.11%) 
Hepatitis Acute  1  0/951 (0.00%)  1/951 (0.11%) 
Hepatitis Toxic  1  0/951 (0.00%)  1/951 (0.11%) 
Immune system disorders     
Sarcoidosis  1  0/951 (0.00%)  1/951 (0.11%) 
Infections and infestations     
Appendicitis  1  4/951 (0.42%)  4/951 (0.42%) 
Gastroenteritis  1  2/951 (0.21%)  3/951 (0.32%) 
Pneumonia  1  3/951 (0.32%)  3/951 (0.32%) 
Pyelonephritis Acute  1  3/951 (0.32%)  1/951 (0.11%) 
Respiratory Tract Infection  1  3/951 (0.32%)  0/951 (0.00%) 
Bronchitis  1  1/951 (0.11%)  2/951 (0.21%) 
Hepatitis B  1  2/951 (0.21%)  0/951 (0.00%) 
Localised Infection  1  2/951 (0.21%)  0/951 (0.00%) 
Pilonidal Cyst  1  2/951 (0.21%)  0/951 (0.00%) 
Postoperative Wound Infection  1  2/951 (0.21%)  0/951 (0.00%) 
Pyelonephritis  1  0/951 (0.00%)  2/951 (0.21%) 
Sepsis  1  2/951 (0.21%)  1/951 (0.11%) 
Upper Respiratory Tract Infection  1  2/951 (0.21%)  1/951 (0.11%) 
Viral Infection  1  1/951 (0.11%)  2/951 (0.21%) 
Abdominal Abscess  1  0/951 (0.00%)  1/951 (0.11%) 
Abdominal Wall Abscess  1  1/951 (0.11%)  0/951 (0.00%) 
Abscess  1  1/951 (0.11%)  0/951 (0.00%) 
Abscess Limb  1  0/951 (0.00%)  1/951 (0.11%) 
Acute Tonsillitis  1  0/951 (0.00%)  1/951 (0.11%) 
Adnexitis  1  1/951 (0.11%)  0/951 (0.00%) 
Bronchopneumonia  1  1/951 (0.11%)  0/951 (0.00%) 
Carbuncle  1  1/951 (0.11%)  0/951 (0.00%) 
Cellulitis  1  1/951 (0.11%)  1/951 (0.11%) 
Corneal Infection  1  0/951 (0.00%)  1/951 (0.11%) 
Empyema  1  1/951 (0.11%)  0/951 (0.00%) 
Encephalitis Viral  1  0/951 (0.00%)  1/951 (0.11%) 
Gastrointestinal Infection  1  0/951 (0.00%)  1/951 (0.11%) 
Groin Abscess  1  1/951 (0.11%)  0/951 (0.00%) 
Hepatitis A  1  1/951 (0.11%)  0/951 (0.00%) 
Hepatitis C  1  1/951 (0.11%)  0/951 (0.00%) 
Herpes Zoster  1  0/951 (0.00%)  1/951 (0.11%) 
Infected Cyst  1  1/951 (0.11%)  0/951 (0.00%) 
Liver Abscess  1  0/951 (0.00%)  1/951 (0.11%) 
Lower Respiratory Tract Infection  1  1/951 (0.11%)  1/951 (0.11%) 
Oophoritis  1  0/951 (0.00%)  1/951 (0.11%) 
Osteomyelitis  1  1/951 (0.11%)  1/951 (0.11%) 
Pelvic Inflammatory Disease  1  0/951 (0.00%)  1/951 (0.11%) 
Perianal Abscess  1  1/951 (0.11%)  1/951 (0.11%) 
Perineal Abscess  1  1/951 (0.11%)  0/951 (0.00%) 
Peritonsillar Abscess  1  1/951 (0.11%)  1/951 (0.11%) 
Pulmonary Tuberculosis  1  1/951 (0.11%)  0/951 (0.00%) 
Pyelonephritis Chronic  1  0/951 (0.00%)  1/951 (0.11%) 
Retroperitoneal Abscess  1  0/951 (0.00%)  1/951 (0.11%) 
Subcutaneous Abscess  1  0/951 (0.00%)  1/951 (0.11%) 
Viral Diarrhoea  1  1/951 (0.11%)  0/951 (0.00%) 
Viral Skin Infection  1  0/951 (0.00%)  1/951 (0.11%) 
Wound Infection Staphylococcal  1  1/951 (0.11%)  0/951 (0.00%) 
Injury, poisoning and procedural complications     
Road Traffic Accident  1  4/951 (0.42%)  2/951 (0.21%) 
Meniscus Lesion  1  0/951 (0.00%)  3/951 (0.32%) 
Multiple Injuries  1  2/951 (0.21%)  3/951 (0.32%) 
Hand Fracture  1  2/951 (0.21%)  1/951 (0.11%) 
Humerus Fracture  1  2/951 (0.21%)  0/951 (0.00%) 
Ligament Injury  1  0/951 (0.00%)  2/951 (0.21%) 
Lower Limb Fracture  1  2/951 (0.21%)  2/951 (0.21%) 
Overdose  1  1/951 (0.11%)  2/951 (0.21%) 
Accidental Overdose  1  0/951 (0.00%)  1/951 (0.11%) 
Ankle Fracture  1  1/951 (0.11%)  0/951 (0.00%) 
Cartilage Injury  1  1/951 (0.11%)  1/951 (0.11%) 
Cervical Vertebral Fracture  1  1/951 (0.11%)  0/951 (0.00%) 
Concussion  1  0/951 (0.00%)  1/951 (0.11%) 
Contusion  1  0/951 (0.00%)  1/951 (0.11%) 
Epicondylitis  1  0/951 (0.00%)  1/951 (0.11%) 
Femur Fracture  1  1/951 (0.11%)  0/951 (0.00%) 
Foot Fracture  1  1/951 (0.11%)  0/951 (0.00%) 
Frostbite  1  0/951 (0.00%)  1/951 (0.11%) 
Gun Shot Wound  1  1/951 (0.11%)  0/951 (0.00%) 
Hip Fracture  1  1/951 (0.11%)  0/951 (0.00%) 
Injury Corneal  1  0/951 (0.00%)  1/951 (0.11%) 
Intentional Overdose  1  1/951 (0.11%)  0/951 (0.00%) 
Intervertebral Disc Injury  1  1/951 (0.11%)  0/951 (0.00%) 
Joint Dislocation  1  1/951 (0.11%)  0/951 (0.00%) 
Joint Injury  1  0/951 (0.00%)  1/951 (0.11%) 
Ligament Rupture  1  1/951 (0.11%)  0/951 (0.00%) 
Limb Injury  1  1/951 (0.11%)  0/951 (0.00%) 
Multiple Fractures  1  0/951 (0.00%)  1/951 (0.11%) 
Patella Fracture  1  0/951 (0.00%)  1/951 (0.11%) 
Radius Fracture  1  1/951 (0.11%)  0/951 (0.00%) 
Skin Laceration  1  0/951 (0.00%)  1/951 (0.11%) 
Skull Fractured Base  1  1/951 (0.11%)  0/951 (0.00%) 
Sports Injury  1  1/951 (0.11%)  0/951 (0.00%) 
Tendon Injury  1  1/951 (0.11%)  0/951 (0.00%) 
Thermal Burn  1  0/951 (0.00%)  1/951 (0.11%) 
Tibia Fracture  1  1/951 (0.11%)  0/951 (0.00%) 
Investigations     
Hepatitis C Positive  1  0/951 (0.00%)  1/951 (0.11%) 
Tumour Marker Increased  1  0/951 (0.00%)  1/951 (0.11%) 
Metabolism and nutrition disorders     
Diabetic Ketoacidosis  1  26/951 (2.73%)  17/951 (1.79%) 
Hypoglycaemia  1  16/951 (1.68%)  24/951 (2.52%) 
Hyperglycaemia  1  8/951 (0.84%)  13/951 (1.37%) 
Diabetes Mellitus Inadequate Control  1  11/951 (1.16%)  8/951 (0.84%) 
Ketoacidosis  1  1/951 (0.11%)  6/951 (0.63%) 
Hypoglycaemic Seizure  1  4/951 (0.42%)  0/951 (0.00%) 
Dehydration  1  1/951 (0.11%)  1/951 (0.11%) 
Diabetic Foot  1  1/951 (0.11%)  0/951 (0.00%) 
Musculoskeletal and connective tissue disorders     
Periarthritis  1  4/951 (0.42%)  1/951 (0.11%) 
Intervertebral Disc Protrusion  1  0/951 (0.00%)  3/951 (0.32%) 
Musculoskeletal Chest Pain  1  2/951 (0.21%)  0/951 (0.00%) 
Osteoarthritis  1  0/951 (0.00%)  2/951 (0.21%) 
Arthralgia  1  1/951 (0.11%)  0/951 (0.00%) 
Arthritis  1  0/951 (0.00%)  1/951 (0.11%) 
Dupuytren's Contracture  1  1/951 (0.11%)  0/951 (0.00%) 
Myopathy  1  0/951 (0.00%)  1/951 (0.11%) 
Osteoarthropathy  1  1/951 (0.11%)  0/951 (0.00%) 
Rotator Cuff Syndrome  1  0/951 (0.00%)  1/951 (0.11%) 
Spondylolisthesis  1  1/951 (0.11%)  0/951 (0.00%) 
Tenosynovitis  1  0/951 (0.00%)  1/951 (0.11%) 
Trigger Finger  1  1/951 (0.11%)  1/951 (0.11%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Fibroadenoma Of Breast  1  0/951 (0.00%)  2/951 (0.21%) 
Malignant Melanoma  1  2/951 (0.21%)  0/951 (0.00%) 
Anaplastic Astrocytoma  1  1/951 (0.11%)  0/951 (0.00%) 
Benign Colonic Neoplasm  1  0/951 (0.00%)  1/951 (0.11%) 
Fibroma  1  1/951 (0.11%)  0/951 (0.00%) 
Hepatic Adenoma  1  1/951 (0.11%)  0/951 (0.00%) 
Lymphoma  1  1/951 (0.11%)  0/951 (0.00%) 
Ovarian Adenoma  1  0/951 (0.00%)  1/951 (0.11%) 
Papillary Thyroid Cancer  1  1/951 (0.11%)  0/951 (0.00%) 
Penile Wart  1  0/951 (0.00%)  1/951 (0.11%) 
Uterine Leiomyoma  1  0/951 (0.00%)  1/951 (0.11%) 
Nervous system disorders     
Hypoglycaemic Coma  1  3/951 (0.32%)  5/951 (0.53%) 
Carpal Tunnel Syndrome  1  4/951 (0.42%)  1/951 (0.11%) 
Diabetic Coma  1  2/951 (0.21%)  0/951 (0.00%) 
Diabetic Neuropathy  1  0/951 (0.00%)  2/951 (0.21%) 
Grand Mal Convulsion  1  2/951 (0.21%)  1/951 (0.11%) 
Amnesia  1  1/951 (0.11%)  0/951 (0.00%) 
Cerebral Haemorrhage  1  1/951 (0.11%)  0/951 (0.00%) 
Cerebrovascular Accident  1  1/951 (0.11%)  1/951 (0.11%) 
Diabetic Hyperosmolar Coma  1  1/951 (0.11%)  0/951 (0.00%) 
Diabetic Ketoacidotic Hyperglycaemic Coma  1  0/951 (0.00%)  1/951 (0.11%) 
Dizziness  1  0/951 (0.00%)  1/951 (0.11%) 
Encephalopathy  1  1/951 (0.11%)  0/951 (0.00%) 
Haemorrhagic Stroke  1  0/951 (0.00%)  1/951 (0.11%) 
Headache  1  0/951 (0.00%)  1/951 (0.11%) 
Migraine  1  0/951 (0.00%)  1/951 (0.11%) 
Multiple Sclerosis  1  1/951 (0.11%)  0/951 (0.00%) 
Myelitis  1  1/951 (0.11%)  0/951 (0.00%) 
Sciatica  1  0/951 (0.00%)  1/951 (0.11%) 
Syncope  1  0/951 (0.00%)  1/951 (0.11%) 
Tension Headache  1  0/951 (0.00%)  1/951 (0.11%) 
Pregnancy, puerperium and perinatal conditions     
Abortion Spontaneous  1  0/951 (0.00%)  1/951 (0.11%) 
Foetal Cardiac Disorder  1  0/951 (0.00%)  1/951 (0.11%) 
Intra-Uterine Death  1  1/951 (0.11%)  0/951 (0.00%) 
Polyhydramnios  1  0/951 (0.00%)  1/951 (0.11%) 
Psychiatric disorders     
Depression  1  1/951 (0.11%)  1/951 (0.11%) 
Major Depression  1  0/951 (0.00%)  1/951 (0.11%) 
Suicide Attempt  1  0/951 (0.00%)  1/951 (0.11%) 
Renal and urinary disorders     
Nephrolithiasis  1  2/951 (0.21%)  0/951 (0.00%) 
Calculus Urinary  1  1/951 (0.11%)  0/951 (0.00%) 
Diabetic Nephropathy  1  0/951 (0.00%)  1/951 (0.11%) 
Haematuria  1  1/951 (0.11%)  0/951 (0.00%) 
Renal Failure  1  0/951 (0.00%)  1/951 (0.11%) 
Ureteric Stenosis  1  0/951 (0.00%)  1/951 (0.11%) 
Reproductive system and breast disorders     
Adenomyosis  1  0/951 (0.00%)  2/951 (0.21%) 
Cervical Dysplasia  1  1/951 (0.11%)  0/951 (0.00%) 
Dysfunctional Uterine Bleeding  1  0/951 (0.00%)  1/951 (0.11%) 
Endometriosis  1  1/951 (0.11%)  0/951 (0.00%) 
Menometrorrhagia  1  1/951 (0.11%)  0/951 (0.00%) 
Menorrhagia  1  1/951 (0.11%)  1/951 (0.11%) 
Ovarian Cyst  1  0/951 (0.00%)  1/951 (0.11%) 
Pelvic Pain  1  0/951 (0.00%)  1/951 (0.11%) 
Uterine Polyp  1  1/951 (0.11%)  0/951 (0.00%) 
Varicocele  1  1/951 (0.11%)  0/951 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Bronchitis Chronic  1  0/951 (0.00%)  1/951 (0.11%) 
Chronic Obstructive Pulmonary Disease  1  0/951 (0.00%)  1/951 (0.11%) 
Haemoptysis  1  0/951 (0.00%)  1/951 (0.11%) 
Nasal Congestion  1  1/951 (0.11%)  0/951 (0.00%) 
Nasal Polyps  1  1/951 (0.11%)  0/951 (0.00%) 
Nasal Septum Deviation  1  1/951 (0.11%)  0/951 (0.00%) 
Pneumomediastinum  1  1/951 (0.11%)  0/951 (0.00%) 
Tonsillar Hypertrophy  1  1/951 (0.11%)  0/951 (0.00%) 
Vocal Cord Polyp  1  1/951 (0.11%)  0/951 (0.00%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  1/951 (0.11%)  0/951 (0.00%) 
Dermal Cyst  1  1/951 (0.11%)  0/951 (0.00%) 
Erythema Nodosum  1  1/951 (0.11%)  0/951 (0.00%) 
Skin Ulcer  1  1/951 (0.11%)  0/951 (0.00%) 
Urticaria  1  0/951 (0.00%)  1/951 (0.11%) 
Vascular disorders     
Hypotension  1  2/951 (0.21%)  1/951 (0.11%) 
Femoral Artery Occlusion  1  0/951 (0.00%)  1/951 (0.11%) 
Hypertension  1  1/951 (0.11%)  0/951 (0.00%) 
Thrombosis  1  0/951 (0.00%)  1/951 (0.11%) 
Varicose Vein  1  0/951 (0.00%)  1/951 (0.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Candesartan Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   92/951 (9.67%)   32/951 (3.36%) 
Vascular disorders     
Hypotension  1  92/951 (9.67%)  32/951 (3.36%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Niklas Berglind, GPS Atacand
Organization: AstraZeneca
Phone: +46 31 7766310
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00252720     History of Changes
Other Study ID Numbers: D2453C00046
DIRECT
SH-AHM-0046
First Submitted: November 10, 2005
First Posted: November 15, 2005
Results First Submitted: March 19, 2012
Results First Posted: June 3, 2014
Last Update Posted: June 3, 2014